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FDA OKs Next-Gen Cologuard Test for CRC Screening
Developed in collaboration with Mayo Clinic, the company noted in the news release announcing its approval that this noninvasive test “raises the performance bar.”
The company says the enhanced sensitivity will help minimize unnecessary follow-up colonoscopy procedures by reducing the odds of a false-positive screening test.
Enhanced sample stability components also will give patients more time to return their sample to the lab.
Cologuard Plus tests for three novel methylated DNA markers and fecal hemoglobin.
The BLUE-C Study
The FDA’s approval was based on the results of the BLUE-C study involving more than 20,000 adults at average risk for CRC that compared the next-generation mt-sDNA test with a fecal immunochemical test (FIT) and colonoscopy.
According to the BLUE-C results, the sensitivities of Cologuard Plus were 95% for CRC and 43% for advanced precancerous lesions, at 94% specificity with no findings on colonoscopy.
The BLUE-C results also showed that the test significantly outperformed FIT for sensitivity for CRC overall, CRC stages I-III, high-grade dysplasia, and advanced precancerous lesions.
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early — when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” Thomas F. Imperiale, MD, AGAF, professor of medicine at the Indiana University School of Medicine and research scientist at the Regenstrief Institute, said in the news release.
“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients,” said Dr. Imperiale, who served as principal investigator of the BLUE-C study.
The company plans to launch Cologuard Plus in 2025.
They anticipate that it will be covered by Medicare and included in the United States Preventive Services Task Force (USPSTF) guidelines and within quality measures.
A version of this article first appeared on Medscape.com.
Developed in collaboration with Mayo Clinic, the company noted in the news release announcing its approval that this noninvasive test “raises the performance bar.”
The company says the enhanced sensitivity will help minimize unnecessary follow-up colonoscopy procedures by reducing the odds of a false-positive screening test.
Enhanced sample stability components also will give patients more time to return their sample to the lab.
Cologuard Plus tests for three novel methylated DNA markers and fecal hemoglobin.
The BLUE-C Study
The FDA’s approval was based on the results of the BLUE-C study involving more than 20,000 adults at average risk for CRC that compared the next-generation mt-sDNA test with a fecal immunochemical test (FIT) and colonoscopy.
According to the BLUE-C results, the sensitivities of Cologuard Plus were 95% for CRC and 43% for advanced precancerous lesions, at 94% specificity with no findings on colonoscopy.
The BLUE-C results also showed that the test significantly outperformed FIT for sensitivity for CRC overall, CRC stages I-III, high-grade dysplasia, and advanced precancerous lesions.
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early — when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” Thomas F. Imperiale, MD, AGAF, professor of medicine at the Indiana University School of Medicine and research scientist at the Regenstrief Institute, said in the news release.
“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients,” said Dr. Imperiale, who served as principal investigator of the BLUE-C study.
The company plans to launch Cologuard Plus in 2025.
They anticipate that it will be covered by Medicare and included in the United States Preventive Services Task Force (USPSTF) guidelines and within quality measures.
A version of this article first appeared on Medscape.com.
Developed in collaboration with Mayo Clinic, the company noted in the news release announcing its approval that this noninvasive test “raises the performance bar.”
The company says the enhanced sensitivity will help minimize unnecessary follow-up colonoscopy procedures by reducing the odds of a false-positive screening test.
Enhanced sample stability components also will give patients more time to return their sample to the lab.
Cologuard Plus tests for three novel methylated DNA markers and fecal hemoglobin.
The BLUE-C Study
The FDA’s approval was based on the results of the BLUE-C study involving more than 20,000 adults at average risk for CRC that compared the next-generation mt-sDNA test with a fecal immunochemical test (FIT) and colonoscopy.
According to the BLUE-C results, the sensitivities of Cologuard Plus were 95% for CRC and 43% for advanced precancerous lesions, at 94% specificity with no findings on colonoscopy.
The BLUE-C results also showed that the test significantly outperformed FIT for sensitivity for CRC overall, CRC stages I-III, high-grade dysplasia, and advanced precancerous lesions.
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early — when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” Thomas F. Imperiale, MD, AGAF, professor of medicine at the Indiana University School of Medicine and research scientist at the Regenstrief Institute, said in the news release.
“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients,” said Dr. Imperiale, who served as principal investigator of the BLUE-C study.
The company plans to launch Cologuard Plus in 2025.
They anticipate that it will be covered by Medicare and included in the United States Preventive Services Task Force (USPSTF) guidelines and within quality measures.
A version of this article first appeared on Medscape.com.
A CRC Blood Test Is Here. What Does it Mean for Screening?
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
In July, the US Food and Drug Administration (FDA) approved the first blood-based test to screen for colorectal cancer (CRC).
The FDA’s approval of Shield (Guardant Health) marks a notable achievement, as individuals at average risk now have the option to receive a simple blood test for CRC screening, starting at age 45.
“No one has an excuse anymore not to be screened,” said John Marshall, MD, director of The Ruesch Center for the Cure of Gastrointestinal Cancers and chief medical officer of the Lombardi Comprehensive Cancer Center at the Georgetown University Medical Center in Washington, DC.
The approval was based on findings from the ECLIPSE study, which reported that Shield had 83% sensitivity for CRC and 90% specificity for advanced neoplasia, though only 13% sensitivity for advanced precancerous lesions.
While an exciting option, the test has its pros and cons.
The bad news, however, is that it does a poor job of detecting precancerous lesions. This could snowball if patients decide to replace a colonoscopy — which helps both detect and prevent CRC — with the blood test.
This news organization spoke to experts across three core specialties involved in the screening and treatment of CRC — primary care, gastroenterology, and oncology — to better understand both the potential value and potential pitfalls of this new option.
The interview responses have been condensed and edited for clarity.
What does this FDA approval mean for CRC screening?
David Lieberman, MD, gastroenterologist and professor emeritus at Oregon Health & Science University: Detecting circulating-free DNA associated with CRC in blood is a major scientific breakthrough. The ease of blood testing will appeal to patients and providers.
Folasade May, MD, director of the gastroenterology quality improvement program at the University of California, Los Angeles: The FDA approval means that we continue to broaden the scope of available tools to help reduce the impact of this largely preventable disease.
Dr. Marshall: Colonoscopy is still the gold standard, but we have to recognize that not everyone does it. And that not everyone wants to send their poop in the mail (with a stool-based test). Now there are no more excuses.
Alan Venook, MD, gastrointestinal medical oncologist at the University of California, San Francisco: Although it’s good to have a blood test that’s approved for CRC screening, I don’t think it moves the bar much in terms of screening. I worry about it overpromising and under-delivering. If it could find polyps or premalignant lesions, that would make a big difference; however, at 13%, that doesn’t really register, so this doesn’t really change anything.
Kenny Lin, MD, a family physician at Penn Medicine Lancaster General Health: I see this test as a good option for the 30% people of CRC screening age who are either not being screened or out of date for screening. I’m a little concerned about the people who are already getting recommended screening and may try to switch to this option.
William Golden, MD, internist and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, Arkansas: On a scale of 1-10, I give it a 2. It’s expensive ($900 per test without insurance). It’s also not sensitive for early cancers, which would be its main value. Frankly, there are better strategies to get patients engaged.
What do you see as the pros and cons of this test?
Dr. Lin: The pros are that it’s very convenient for patients, and it’s especially easy for physicians if they have a lab in their office and can avoid a referral where patients may never get the test. However, the data I saw were disappointing, with sensitivity and specificity falling short of the stool-based Cologuard test, which is also not invasive and less likely to miss early cancers, precancerous lesions, and polyps.
Dr. Lieberman: A major con is the detection rate of only 13% for advanced precancerous lesions, which means that this test is not likely to result in much cancer prevention. There is good evidence that if advanced precancerous lesions are detected and removed, many — if not most — CRCs can be prevented.
Dr. Marshall: Another issue is the potential for a false-positive result (which occurs for 1 in every 10 tests). With this result, you would do a scope but can’t find what’s going on. This is a big deal. It’s the first of the blood tests that will be used for cancer screening, and it could be scary for a patient to receive a positive result but not be able to figure out where it’s coming from.
Will you be recommending this test or relying on its results?
Dr. Lieberman: Patients need to understand that the blood test is inferior to every other screening test and, if selected, would result in less protection against developing CRC or dying from CRC than other screening tests. But models suggest that this test will perform better than no screening. Therefore, it is reasonable to offer the test to individuals who decline any other form of screening.
Dr. May: I will do what I’ve always done — after the FDA approval, I wait for the US Preventive Services Task Force (USPSTF) to endorse it. If it does, then I feel it’s my responsibility to tell my patients about all the options they have and stay up to date on how the tests perform, what the pros and cons are, and what reliable information will help patients make the best decision.
Dr. Venook: No, but I could potentially see us moving it into surveillance mode, where CRC survivors or patients undergoing therapy could take it, which might give us a unique second bite of the apple. The test could potentially be of value in identifying early relapse or recurrence, which might give us a heads-up or jump start on follow-up.
Are you concerned that patients won’t return for a colonoscopy after a positive result?
Dr. Golden: This concern is relevant for all tests, including fecal immunochemical test (FIT), but I’ve found that if the patient is willing to do the initial test and it comes back positive, most are willing to do the follow-up. Of course, some folks have issues with this, but now we’ll have a marker in their medical records and can re-engage them through outreach.
Dr. Lieberman: I am concerned that a patient who previously declined to have a colonoscopy may not follow up an abnormal blood test with a colonoscopy. If this occurs, it will render a blood test program ineffective for those patients. Patients should be told upfront that if the test is abnormal, a colonoscopy would be recommended.
Dr. May: This is a big concern that I have. We already have two-step screening processes with FIT, Cologuard, and CT colonography, and strong data show there is attrition. All doctors and companies will need to make it clear that if patients have an abnormal test result, they must undergo a colonoscopy. We must have activated and involved systems of patient follow-up and navigation.
Dr. Lin: I already have some concerns, given that some patients with positive FIT tests don’t get timely follow-up. I see it in my own practice where we call patients to get a colonoscopy, but they don’t take it seriously or their initial counseling wasn’t clear about the possibility of needing a follow-up colonoscopy. If people aren’t being screened for whatever reason in the first place and they get a positive result on the Shield blood test, they might be even less likely to get the necessary follow-up testing afterward.
What might this mean for insurance coverage and costs for patients?
Dr. May: This is an important question because if we don’t have equal access, we create or widen disparities. For insurers to cover Shield, it’ll need to be endorsed by major medical societies, including USPSTF. But what will happen in the beginning is that wealthy patients who can pay out of pocket will use it, while lower-income individuals won’t have access until insurers cover it.
Dr. Golden: I could do 70 (or more) FIT tests for the cost of this one blood test. A FIT test should be offered first. We’re advising the Medicaid program that physicians should be required to explain why a patient doesn’t want a FIT test, prior to covering this blood test.
Dr. Venook: It’s too early to say. Although it’s approved, we now have to look at the monetization factor. At the end of the day, we still need a colonoscopy. The science is impressive, but it doesn’t mean we need to spend $900 doing a blood test.
Dr. Lin: I could see the coverage trajectory being similar to that for Cologuard, which had little coverage when it came out 10 years ago, but eventually, Medicare and commercial coverage happened. With Shield, initially, there will be some coverage gaps, especially with commercial insurance, and I can see insurance companies having concerns, especially because the test is expensive compared with other tests and the return isn’t well known. It could also be a waste of money if people with positive tests don’t receive follow-up colonoscopies.
What else would you like to share that people may not have considered?
Dr. Marshall: These tests could pick up other genes from other cancers. My worry is that people could have another cancer detected but not find it on a colonoscopy and think the blood test must be wrong. Or they’ll do a scan, which could lead to more scans and tests.
Dr. Golden: This test has received a lot of attention and coverage that didn’t discuss other screening options, limitations, or nuances. Let’s face it — we’ll see lots of TV ads about it, but once we start dealing with the total cost of care and alternate payment models, it’s going to be hard for this test to find a niche.
Dr. Venook: This test has only been validated in a population of ages 45 years or older, which is the conventional screening population. We desperately need something that can work in younger people, where CRC rates are increasing. I’d like to see the research move in that direction.
Dr. Lin: I thought it was unique that the FDA Advisory Panel clearly stated this was better than nothing but also should be used as second-line screening. The agency took pains to say this is not a colonoscopy or even equivalent to the fecal tests in use. But they appropriately did approve it because a lot of people aren’t getting anything at all, which is the biggest problem with CRC screening.
A version of this article first appeared on Medscape.com.
Five Steps to Improved Colonoscopy Performance
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
According to several experts who spoke at the American Gastroenterological Association’s Postgraduate Course this spring, which was offered at Digestive Disease Week (DDW), gastroenterologists can take these five steps to improve their performance: Addressing poor bowel prep, improving polyp detection, following the best intervals for polyp surveillance, reducing the environmental impact of gastrointestinal (GI) practice, and implementing artificial intelligence (AI) tools for efficiency and quality.
Addressing Poor Prep
To improve bowel preparation rates, clinicians may consider identifying those at high risk for inadequate prep, which could include known risk factors such as age, body mass index, inpatient status, constipation, tobacco use, and hypertension. However, other variables tend to serve as bigger predictors of inadequate prep, such as the patient’s status regarding cirrhosis, Parkinson’s disease, dementia, diabetes, opioid use, gastroparesis, tricyclics, and colorectal surgery.
Although several prediction models are based on some of these factors — looking at comorbidities, antidepressant use, constipation, and prior abdominal or pelvic surgery — the data don’t indicate whether knowing about or addressing these risks actually leads to better bowel prep, said Brian Jacobson, MD, associate professor of medicine at Harvard Medical School, Boston, and director of program development for gastroenterology at Massachusetts General Hospital in Boston.
Instead, the biggest return-on-investment option is to maximize prep for all patients, he said, especially since every patient has at least some risk of poor prep, either due to the required diet changes, medication considerations, or purgative solution and timing.
To create a state-of-the-art bowel prep process, Dr. Jacobson recommended numerous tactics for all patients: Verbal and written instructions for all components of prep, patient navigation with phone or virtual messaging to guide patients through the process, a low-fiber or all-liquid diet on the day before colonoscopy, and a split-dose 2-L prep regimen. Patients should begin the second half of the split-dose regimen 4-6 hours before colonoscopy and complete it at least 2 hours before the procedure starts, and clinicians should use an irrigation pump during colonoscopy to improve visibility.
Beyond that, Dr. Jacobson noted, higher risk patients can take a split-dose 4-L prep regimen with bisacodyl, a low-fiber diet 2-3 days before colonoscopy, and a clear liquid diet the day before colonoscopy. Using simethicone as an adjunct solution can also reduce bubbles in the colon.
Future tech developments may help clinicians as well, he said, such as using AI to identify patients at high risk and modifying their prep process, creating a personalized prep on a digital platform with videos that guide patients through the process, and using a phone checklist tool to indicate when they’re ready for colonoscopy.
Improving Polyp Detection
Adenoma detection rates (ADR) can be highly variable due to different techniques, technical skills, pattern recognition, interpretation, and experience. New adjunct and AI-based tools can help improve ADR, especially if clinicians want to improve, receive training, and use best-practice techniques.
“In colonoscopy, it’s tricky because it’s not just a blood test or an x-ray. There’s really a lot of technique involved, both cognitive awareness and pattern recognition, as well as our technical skills,” said Tonya Kaltenbach, MD, professor of clinical medicine at the University of California San Francisco and director of advanced endoscopy at the San Francisco VA Health Care System in San Francisco.
For instance, multiple tools and techniques may be needed in real time to interpret a lesion, such as washing, retroflexing, and using better lighting, while paying attention to alerts and noting areas for further inspection and resection.
“This is not innate. It’s a learned skill,” she said. “It’s something we need to intentionally make efforts on and get feedback to improve.”
Improvement starts with using the right mindset for lesion detection, Dr. Kaltenbach said, by having a “reflexive recognition of deconstructed patterns of normal” — following the lines, vessels, and folds and looking for interruptions, abnormal thickness, and mucus caps. On top of that, adjunctive tools such as caps/cuffs and dye chromoendoscopy can help with proper ergonomics, irrigation, and mucosa exposure.
In the past 3 years, real-world studies using AI and computer-assisted detection have shown mixed results, with some demonstrating significant increases in ADR, while others haven’t, she said. However, being willing to try AI and other tools, such as the Endocuff cap, may help improve ADR, standardize interpretation, improve efficiency, and increase reproducibility.
“We’re always better with intentional feedback and deliberate practice,” she said. “Remember that if you improve, you’re protecting the patient from death and reducing interval cancer.”
Following Polyp Surveillance Intervals
The US Multi-Society Task Force on Colorectal Cancer’s recommendations for follow-up after colonoscopy and polypectomy provide valuable information and rationale for how to determine surveillance intervals for patients. However, clinicians still may be unsure what to recommend for some patients — or tell them to come back too soon, leading to unnecessary colonoscopy.
For instance, a 47-year-old woman who presents for her initial screening and has a single 6-mm polyp, which pathology returns as a single adenoma may be considered to be at average risk and suggested to return in 7-10 years. The guidelines seem more obvious for patients with one or two adenomas under 10 mm removed en bloc.
However, once the case details shift into gray areas and include three or four adenomas between 10 and 20 mm, or piecemeal removal, clinicians may differ on their recommendations, said Rajesh N. Keswani, MD, associate professor of medicine at the Northwestern University Feinberg School of Medicine and director of endoscopy for Northwestern Medicine in Chicago. At DDW 2024, Dr. Keswani presented several case examples, often finding various audience opinions.
In addition, he noted, recent studies have found that clinicians may estimate imprecise polyp measurements, struggle to identify sessile serrated polyposis syndrome, and often don’t follow evidence-based guidelines.
“Why do we ignore the guidelines? There’s this perception that a patient has risk factors that aren’t addressed by the guidelines, with regards to family history or a distant history of a large polyp that we don’t want to leave to the usual intervals,” he said. “We feel uncomfortable, even with our meticulous colonoscopy, telling people to come back in 10 years.”
To improve guideline adherence, Dr. Keswani suggested providing additional education, implementing an automated surveillance calculator, and using guidelines at the point of care. At Northwestern, for instance, clinicians use a hyperlink with an interpreted version of the guidelines with prior colonoscopy considerations. Overall though, practitioners should feel comfortable leaning toward longer surveillance intervals, he noted.
“More effort should be spent on getting unscreened patients in for colonoscopy than bringing back low-risk patients too early,” he said.
Reducing Environmental Effects
In recent waste audits of endoscopy rooms, providers generate 1-3 kg of waste per procedure, which would fill 117 soccer fields to a depth of 1 m, based on 18 million procedures in the United States per year. This waste comes from procedure-related equipment, administration, medications, travel of patients and staff, and infrastructure with systems such as air conditioning. Taking steps toward a green practice can reduce waste and the carbon footprint of healthcare.
“When we think about improving colonoscopy performance, the goal is to prevent colon cancer death, but when we expand that, we have to apply sustainable practices as a domain of quality,” said Heiko Pohl, MD, professor of medicine at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire, and a gastroenterologist at White River Junction VA Medical Center in White River Junction, Vermont.
The GI Multisociety Strategic Plan on Environmental Sustainability suggests a 5-year initiative to improve sustainability and reduce waste across seven domains — clinical setting, education, research, society efforts, intersociety efforts, industry, and advocacy.
For instance, clinicians can take the biggest step toward sustainability by avoiding unneeded colonoscopies, Dr. Pohl said, noting that between 20% and 30% aren’t appropriate or indicated. Instead, practitioners can implement longer surveillance intervals, adhere to guidelines, and consider alternative tests, such as the fecal immunochemical test, fecal DNA, blood-based tests, and CT colonography, where relevant.
Clinicians can also rethink their approach to resection, such as using a snare first instead of forceps to reduce single-instrument use, using clip closure only when it’s truly indicated, and implementing AI-assisted optical diagnosis to help with leaving rectosigmoid polyps in place.
In terms of physical waste, practices may also reconsider how they sort bins and biohazards, looking at new ways to dispose of regulated medical waste, sharps, recyclables, and typical trash. Waste audits can help find ways to reduce paper, combine procedures, and create more efficient use of endoscopy rooms.
“We are really in a very precarious situation,” Dr. Pohl said. “It’s our generation that has a responsibility to change the course for our children’s and grandchildren’s sake.”
AI for Quality And Efficiency
Moving forward, AI tools will likely become more popular in various parts of GI practice, by assisting with documentation, spotting polyps, tracking mucosal surfaces, providing optical histopathology, and supervising performance through high-quality feedback.
“Endoscopy has reached the limits of human visual capacity, where seeing more pixels won’t necessarily improve clinical diagnosis. What’s next for elevating the care of patients really is AI,” said Jason B. Samarasena, MD, professor of medicine and program director of the interventional endoscopy training program at the University of California Irvine in Irvine, California.
As practices adopt AI-based systems, however, clinicians should be cautious about a false sense of comfort or “alarm fatigue” if bounding boxes become distracting. Instead, new tools need to be adopted as a “physician-AI hybrid,” with the endoscopist in mind, particularly if helpful for performing a better exam by watching withdrawal time or endoscope slippage.
“In real-world practice, this is being implemented without attention to endoscopist inclination and behavior,” he said. “Having a better understanding of physician attitudes could yield more optimal results.”
Notably, AI-assisted tools should be viewed akin to spell-check, which signals to the endoscopist when to pay attention and double-check an area — but primarily relies on the expert to do a high-quality exam, said Aasma Shaukat, MD, professor of medicine and director of GI outcomes research at the NYU Grossman School of Medicine, New York City.
“This should be an adjunct or an additional tool, not a replacement tool,” she added. “This doesn’t mean to stop doing astute observation.”
Future tools show promise in terms of tracking additional data related to prep quality, cecal landmarks, polyp size, mucosa exposure, histology prediction, and complete resection. These automated reports could also link to real-time dashboards, hospital or national registries, and reimbursement systems, Dr. Shaukat noted.
“At the end of the day, our interests are aligned,” she said. “Everybody cares about quality, patient satisfaction, and reimbursement, and with that goal in mind, I think some of the tools can be applied to show how we can achieve those principles together.”
Dr. Jacobson, Dr. Kaltenbach, Dr. Keswani, Dr. Pohl, Dr. Samarasena, and Dr. Shaukat reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Fecal Immunochemical Test Performance for CRC Screening Varies Widely
, new research suggests.
In a comparative performance analysis of five commonly used FITs for colorectal cancer (CRC) screening, researchers found statistically significant differences in positivity rates, sensitivity, and specificity, as well as important differences in rates of unusable tests.
“Our findings have practical importance for FIT-based screening programs as these differences affect the need for repeated FIT, the yield of ACN detection, and the number of diagnostic colonoscopies that would be required to follow-up on abnormal findings,” wrote the researchers, led by Barcey T. Levy, MD, PhD, with University of Iowa, Iowa City.
The study was published online in Annals of Internal Medicine.
Wide Variation Found
Despite widespread use of FITs for CRC screening, there is limited data to help guide test selection. Understanding the comparative performance of different FITs is “crucial” for a successful FIT-based screening program, the researchers wrote.
Dr. Levy and colleagues directly compared the performance of five commercially available FITs — including four qualitative tests (Hemoccult ICT, Hemosure iFOB, OC-Light S FIT, and QuickVue iFOB) and one quantitative test (OC-Auto FIT) — using colonoscopy as the reference standard.
Participants included a diverse group of 3761 adults (mean age, 62 years; 63% women). Each participant was given all five tests and completed them using the same stool sample. They sent the tests by first class mail to a central location, where FITs were analyzed by a trained professional on the day of receipt.
The primary outcome was test performance (sensitivity and specificity) for ACN, defined as advanced polyps or CRC.
A total of 320 participants (8.5%) were found to have ACN based on colonoscopy results, including nine with CRC (0.2%) — rates that are similar to those found in other studies.
The sensitivity for detecting ACN ranged from 10.1% (Hemoccult ICT) to 36.7% (OC-Light S FIT), and specificity varied from 85.5% (OC-Light S FIT) to 96.6% (Hemoccult ICT).
“Given the variation in FIT cutoffs reported by manufacturers, it is not surprising that tests with lower cutoffs (such as OC-Light S FIT) had higher sensitivity than tests with higher cutoffs (such as Hemoccult ICT),” Dr. Levy and colleagues wrote.
Test positivity rates varied fourfold across FITs, from 3.9% for Hemoccult ICT to 16.4% for OC-Light S FIT.
The rates of tests deemed unevaluable (due to factors such as indeterminant results or user mistakes) ranged from 0.2% for OC-Auto FIT to 2.5% for QuickVue iFOB.
The highest positive predictive value (PPV) was observed with OC-Auto FIT (28.9%) and the lowest with Hemosure iFOB (18.2%). The negative predictive value was similar across tests, ranging from 92.2% to 93.3%, indicating consistent performance in ruling out disease.
The study also identified significant differences in test sensitivity based on factors such as the location of neoplasia (higher sensitivity for distal lesions) and patient characteristics (higher sensitivity in people with higher body mass index and lower income).
Dr. Levy and colleagues said their findings have implications both in terms of clinical benefits and cost-effectiveness of CRC screening using FITs.
“Tests with lower sensitivity will miss more patients with CRC and advanced polyps, and tests with higher sensitivity and lower PPV will require more colonoscopies to detect patients with actionable findings,” they wrote.
‘Jaw-Dropping’ Results
The sensitivity results are “jaw-dropping,” Robert Smith, PhD, senior vice-president for cancer screening at the American Cancer Society, said in an interview. “A patient should have at least a 50/50 chance of having their colorectal cancer detected with a stool test at the time of testing.”
“What these numbers show is that the level that the manufacturers believe their test is performing is not reproduced,” Dr. Smith added.
This study adds to “concerns that have been raised about the inherent limitations and the performance of these tests that have been cleared for use and that are supposed to be lifesaving,” he said.
Clearance by the US Food and Drug Administration should mean that there’s essentially “no risk to using the test in terms of the test itself being harmful,” Dr. Smith said. But that’s not the case with FITs “because it’s harmful if you have cancer and your test doesn’t find it.”
By way of study limitations, Dr. Levy and colleagues said it’s important to note that they did not evaluate the “programmatic” sensitivity of repeating FIT testing every 1-2 years, as is generally recommended in screening guidelines. Therefore, the sensitivity of a single FIT may be lower than that of a repeated FIT. Also, variability in the FIT collection process by participants might have affected the results.
The study had no commercial funding. Disclosures for authors are available with the original article. Dr. Smith had no relevant disclosures.
A version of this article appeared on Medscape.com.
, new research suggests.
In a comparative performance analysis of five commonly used FITs for colorectal cancer (CRC) screening, researchers found statistically significant differences in positivity rates, sensitivity, and specificity, as well as important differences in rates of unusable tests.
“Our findings have practical importance for FIT-based screening programs as these differences affect the need for repeated FIT, the yield of ACN detection, and the number of diagnostic colonoscopies that would be required to follow-up on abnormal findings,” wrote the researchers, led by Barcey T. Levy, MD, PhD, with University of Iowa, Iowa City.
The study was published online in Annals of Internal Medicine.
Wide Variation Found
Despite widespread use of FITs for CRC screening, there is limited data to help guide test selection. Understanding the comparative performance of different FITs is “crucial” for a successful FIT-based screening program, the researchers wrote.
Dr. Levy and colleagues directly compared the performance of five commercially available FITs — including four qualitative tests (Hemoccult ICT, Hemosure iFOB, OC-Light S FIT, and QuickVue iFOB) and one quantitative test (OC-Auto FIT) — using colonoscopy as the reference standard.
Participants included a diverse group of 3761 adults (mean age, 62 years; 63% women). Each participant was given all five tests and completed them using the same stool sample. They sent the tests by first class mail to a central location, where FITs were analyzed by a trained professional on the day of receipt.
The primary outcome was test performance (sensitivity and specificity) for ACN, defined as advanced polyps or CRC.
A total of 320 participants (8.5%) were found to have ACN based on colonoscopy results, including nine with CRC (0.2%) — rates that are similar to those found in other studies.
The sensitivity for detecting ACN ranged from 10.1% (Hemoccult ICT) to 36.7% (OC-Light S FIT), and specificity varied from 85.5% (OC-Light S FIT) to 96.6% (Hemoccult ICT).
“Given the variation in FIT cutoffs reported by manufacturers, it is not surprising that tests with lower cutoffs (such as OC-Light S FIT) had higher sensitivity than tests with higher cutoffs (such as Hemoccult ICT),” Dr. Levy and colleagues wrote.
Test positivity rates varied fourfold across FITs, from 3.9% for Hemoccult ICT to 16.4% for OC-Light S FIT.
The rates of tests deemed unevaluable (due to factors such as indeterminant results or user mistakes) ranged from 0.2% for OC-Auto FIT to 2.5% for QuickVue iFOB.
The highest positive predictive value (PPV) was observed with OC-Auto FIT (28.9%) and the lowest with Hemosure iFOB (18.2%). The negative predictive value was similar across tests, ranging from 92.2% to 93.3%, indicating consistent performance in ruling out disease.
The study also identified significant differences in test sensitivity based on factors such as the location of neoplasia (higher sensitivity for distal lesions) and patient characteristics (higher sensitivity in people with higher body mass index and lower income).
Dr. Levy and colleagues said their findings have implications both in terms of clinical benefits and cost-effectiveness of CRC screening using FITs.
“Tests with lower sensitivity will miss more patients with CRC and advanced polyps, and tests with higher sensitivity and lower PPV will require more colonoscopies to detect patients with actionable findings,” they wrote.
‘Jaw-Dropping’ Results
The sensitivity results are “jaw-dropping,” Robert Smith, PhD, senior vice-president for cancer screening at the American Cancer Society, said in an interview. “A patient should have at least a 50/50 chance of having their colorectal cancer detected with a stool test at the time of testing.”
“What these numbers show is that the level that the manufacturers believe their test is performing is not reproduced,” Dr. Smith added.
This study adds to “concerns that have been raised about the inherent limitations and the performance of these tests that have been cleared for use and that are supposed to be lifesaving,” he said.
Clearance by the US Food and Drug Administration should mean that there’s essentially “no risk to using the test in terms of the test itself being harmful,” Dr. Smith said. But that’s not the case with FITs “because it’s harmful if you have cancer and your test doesn’t find it.”
By way of study limitations, Dr. Levy and colleagues said it’s important to note that they did not evaluate the “programmatic” sensitivity of repeating FIT testing every 1-2 years, as is generally recommended in screening guidelines. Therefore, the sensitivity of a single FIT may be lower than that of a repeated FIT. Also, variability in the FIT collection process by participants might have affected the results.
The study had no commercial funding. Disclosures for authors are available with the original article. Dr. Smith had no relevant disclosures.
A version of this article appeared on Medscape.com.
, new research suggests.
In a comparative performance analysis of five commonly used FITs for colorectal cancer (CRC) screening, researchers found statistically significant differences in positivity rates, sensitivity, and specificity, as well as important differences in rates of unusable tests.
“Our findings have practical importance for FIT-based screening programs as these differences affect the need for repeated FIT, the yield of ACN detection, and the number of diagnostic colonoscopies that would be required to follow-up on abnormal findings,” wrote the researchers, led by Barcey T. Levy, MD, PhD, with University of Iowa, Iowa City.
The study was published online in Annals of Internal Medicine.
Wide Variation Found
Despite widespread use of FITs for CRC screening, there is limited data to help guide test selection. Understanding the comparative performance of different FITs is “crucial” for a successful FIT-based screening program, the researchers wrote.
Dr. Levy and colleagues directly compared the performance of five commercially available FITs — including four qualitative tests (Hemoccult ICT, Hemosure iFOB, OC-Light S FIT, and QuickVue iFOB) and one quantitative test (OC-Auto FIT) — using colonoscopy as the reference standard.
Participants included a diverse group of 3761 adults (mean age, 62 years; 63% women). Each participant was given all five tests and completed them using the same stool sample. They sent the tests by first class mail to a central location, where FITs were analyzed by a trained professional on the day of receipt.
The primary outcome was test performance (sensitivity and specificity) for ACN, defined as advanced polyps or CRC.
A total of 320 participants (8.5%) were found to have ACN based on colonoscopy results, including nine with CRC (0.2%) — rates that are similar to those found in other studies.
The sensitivity for detecting ACN ranged from 10.1% (Hemoccult ICT) to 36.7% (OC-Light S FIT), and specificity varied from 85.5% (OC-Light S FIT) to 96.6% (Hemoccult ICT).
“Given the variation in FIT cutoffs reported by manufacturers, it is not surprising that tests with lower cutoffs (such as OC-Light S FIT) had higher sensitivity than tests with higher cutoffs (such as Hemoccult ICT),” Dr. Levy and colleagues wrote.
Test positivity rates varied fourfold across FITs, from 3.9% for Hemoccult ICT to 16.4% for OC-Light S FIT.
The rates of tests deemed unevaluable (due to factors such as indeterminant results or user mistakes) ranged from 0.2% for OC-Auto FIT to 2.5% for QuickVue iFOB.
The highest positive predictive value (PPV) was observed with OC-Auto FIT (28.9%) and the lowest with Hemosure iFOB (18.2%). The negative predictive value was similar across tests, ranging from 92.2% to 93.3%, indicating consistent performance in ruling out disease.
The study also identified significant differences in test sensitivity based on factors such as the location of neoplasia (higher sensitivity for distal lesions) and patient characteristics (higher sensitivity in people with higher body mass index and lower income).
Dr. Levy and colleagues said their findings have implications both in terms of clinical benefits and cost-effectiveness of CRC screening using FITs.
“Tests with lower sensitivity will miss more patients with CRC and advanced polyps, and tests with higher sensitivity and lower PPV will require more colonoscopies to detect patients with actionable findings,” they wrote.
‘Jaw-Dropping’ Results
The sensitivity results are “jaw-dropping,” Robert Smith, PhD, senior vice-president for cancer screening at the American Cancer Society, said in an interview. “A patient should have at least a 50/50 chance of having their colorectal cancer detected with a stool test at the time of testing.”
“What these numbers show is that the level that the manufacturers believe their test is performing is not reproduced,” Dr. Smith added.
This study adds to “concerns that have been raised about the inherent limitations and the performance of these tests that have been cleared for use and that are supposed to be lifesaving,” he said.
Clearance by the US Food and Drug Administration should mean that there’s essentially “no risk to using the test in terms of the test itself being harmful,” Dr. Smith said. But that’s not the case with FITs “because it’s harmful if you have cancer and your test doesn’t find it.”
By way of study limitations, Dr. Levy and colleagues said it’s important to note that they did not evaluate the “programmatic” sensitivity of repeating FIT testing every 1-2 years, as is generally recommended in screening guidelines. Therefore, the sensitivity of a single FIT may be lower than that of a repeated FIT. Also, variability in the FIT collection process by participants might have affected the results.
The study had no commercial funding. Disclosures for authors are available with the original article. Dr. Smith had no relevant disclosures.
A version of this article appeared on Medscape.com.
Study Questions Relationship Between Crohn’s Strictures and Cancer Risk
, according to investigators.
Although 8% of patients with strictures in a multicenter study were diagnosed with CRC, this diagnosis was made either simultaneously or within 1 year of stricture diagnosis, suggesting that cancer may have driven stricture development, and not the other way around, lead author Thomas Hunaut, MD, of Université de Champagne-Ardenne, Reims, France, and colleagues reported.
“The occurrence of colonic stricture in CD always raises concerns about the risk for dysplasia/cancer,” the investigators wrote in Gastro Hep Advances, noting that no consensus approach is currently available to guide stricture management. “Few studies with conflicting results have evaluated the frequency of CRC associated with colonic stricture in CD, and the natural history of colonic stricture in CD is poorly known.”The present retrospective study included 88 consecutive CD patients with 96 colorectal strictures who were managed at three French referral centers between 1993 and 2022.
Strictures were symptomatic in 62.5% of cases, not passable by scope in 61.4% of cases, and ulcerated in 70.5% of cases. Colonic resection was needed in 47.7% of patients, while endoscopic balloon dilation was performed in 13.6% of patients.
After a median follow-up of 21.5 months, seven patients (8%) were diagnosed with malignant stricture, including five cases of colonic adenocarcinoma, one case of neuroendocrine carcinoma, and one case of B-cell lymphoproliferative neoplasia.
Malignant strictures were more common among older patients with longer disease duration and frequent obstructive symptoms; however, these factors were not supported by multivariate analyses, likely due to sample size, according to the investigators.
Instead, Dr. Hunaut and colleagues highlighted the timing of the diagnoses. In four out of seven patients with malignant stricture, both stricture and cancer were diagnosed at the same time. In the remaining three patients, cancer was diagnosed at 3 months, 8 months, and 12 months after stricture diagnosis. No cases of cancer were diagnosed later than 1 year after the stricture diagnosis.
“We believe that this result is important for the management of colonic strictures complicating CD in clinical practice,” Dr. Hunaut and colleagues wrote.
The simultaneity or proximity of the diagnoses suggests that the “strictures observed are already a neoplastic complication of the colonic inflammatory disease,” they explained.
In other words, common concerns about strictures causing cancer at the same site could be unfounded.
This conclusion echoes a recent administrative database study that reported no independent association between colorectal stricture and CRC, the investigators noted.
“Given the recent evidence on the risk of cancer associated with colonic strictures in CD, systematic colectomy is probably no longer justified,” they wrote. “Factors such as a long disease duration, primary sclerosing cholangitis, a history of dysplasia, and nonpassable and/or symptomatic stricture despite endoscopic dilation tend to argue in favor of surgery — especially if limited resection is possible.”
In contrast, patients with strictures who have low risk of CRC may be better served by a conservative approach, including endoscopy and systematic biopsies, followed by close endoscopic surveillance, according to the investigators. If the stricture is impassable, they recommended endoscopic balloon dilation, followed by intensification of medical therapy if ulceration is observed.
The investigators disclosed relationships with MSD, Ferring, Biogen, and others.
, according to investigators.
Although 8% of patients with strictures in a multicenter study were diagnosed with CRC, this diagnosis was made either simultaneously or within 1 year of stricture diagnosis, suggesting that cancer may have driven stricture development, and not the other way around, lead author Thomas Hunaut, MD, of Université de Champagne-Ardenne, Reims, France, and colleagues reported.
“The occurrence of colonic stricture in CD always raises concerns about the risk for dysplasia/cancer,” the investigators wrote in Gastro Hep Advances, noting that no consensus approach is currently available to guide stricture management. “Few studies with conflicting results have evaluated the frequency of CRC associated with colonic stricture in CD, and the natural history of colonic stricture in CD is poorly known.”The present retrospective study included 88 consecutive CD patients with 96 colorectal strictures who were managed at three French referral centers between 1993 and 2022.
Strictures were symptomatic in 62.5% of cases, not passable by scope in 61.4% of cases, and ulcerated in 70.5% of cases. Colonic resection was needed in 47.7% of patients, while endoscopic balloon dilation was performed in 13.6% of patients.
After a median follow-up of 21.5 months, seven patients (8%) were diagnosed with malignant stricture, including five cases of colonic adenocarcinoma, one case of neuroendocrine carcinoma, and one case of B-cell lymphoproliferative neoplasia.
Malignant strictures were more common among older patients with longer disease duration and frequent obstructive symptoms; however, these factors were not supported by multivariate analyses, likely due to sample size, according to the investigators.
Instead, Dr. Hunaut and colleagues highlighted the timing of the diagnoses. In four out of seven patients with malignant stricture, both stricture and cancer were diagnosed at the same time. In the remaining three patients, cancer was diagnosed at 3 months, 8 months, and 12 months after stricture diagnosis. No cases of cancer were diagnosed later than 1 year after the stricture diagnosis.
“We believe that this result is important for the management of colonic strictures complicating CD in clinical practice,” Dr. Hunaut and colleagues wrote.
The simultaneity or proximity of the diagnoses suggests that the “strictures observed are already a neoplastic complication of the colonic inflammatory disease,” they explained.
In other words, common concerns about strictures causing cancer at the same site could be unfounded.
This conclusion echoes a recent administrative database study that reported no independent association between colorectal stricture and CRC, the investigators noted.
“Given the recent evidence on the risk of cancer associated with colonic strictures in CD, systematic colectomy is probably no longer justified,” they wrote. “Factors such as a long disease duration, primary sclerosing cholangitis, a history of dysplasia, and nonpassable and/or symptomatic stricture despite endoscopic dilation tend to argue in favor of surgery — especially if limited resection is possible.”
In contrast, patients with strictures who have low risk of CRC may be better served by a conservative approach, including endoscopy and systematic biopsies, followed by close endoscopic surveillance, according to the investigators. If the stricture is impassable, they recommended endoscopic balloon dilation, followed by intensification of medical therapy if ulceration is observed.
The investigators disclosed relationships with MSD, Ferring, Biogen, and others.
, according to investigators.
Although 8% of patients with strictures in a multicenter study were diagnosed with CRC, this diagnosis was made either simultaneously or within 1 year of stricture diagnosis, suggesting that cancer may have driven stricture development, and not the other way around, lead author Thomas Hunaut, MD, of Université de Champagne-Ardenne, Reims, France, and colleagues reported.
“The occurrence of colonic stricture in CD always raises concerns about the risk for dysplasia/cancer,” the investigators wrote in Gastro Hep Advances, noting that no consensus approach is currently available to guide stricture management. “Few studies with conflicting results have evaluated the frequency of CRC associated with colonic stricture in CD, and the natural history of colonic stricture in CD is poorly known.”The present retrospective study included 88 consecutive CD patients with 96 colorectal strictures who were managed at three French referral centers between 1993 and 2022.
Strictures were symptomatic in 62.5% of cases, not passable by scope in 61.4% of cases, and ulcerated in 70.5% of cases. Colonic resection was needed in 47.7% of patients, while endoscopic balloon dilation was performed in 13.6% of patients.
After a median follow-up of 21.5 months, seven patients (8%) were diagnosed with malignant stricture, including five cases of colonic adenocarcinoma, one case of neuroendocrine carcinoma, and one case of B-cell lymphoproliferative neoplasia.
Malignant strictures were more common among older patients with longer disease duration and frequent obstructive symptoms; however, these factors were not supported by multivariate analyses, likely due to sample size, according to the investigators.
Instead, Dr. Hunaut and colleagues highlighted the timing of the diagnoses. In four out of seven patients with malignant stricture, both stricture and cancer were diagnosed at the same time. In the remaining three patients, cancer was diagnosed at 3 months, 8 months, and 12 months after stricture diagnosis. No cases of cancer were diagnosed later than 1 year after the stricture diagnosis.
“We believe that this result is important for the management of colonic strictures complicating CD in clinical practice,” Dr. Hunaut and colleagues wrote.
The simultaneity or proximity of the diagnoses suggests that the “strictures observed are already a neoplastic complication of the colonic inflammatory disease,” they explained.
In other words, common concerns about strictures causing cancer at the same site could be unfounded.
This conclusion echoes a recent administrative database study that reported no independent association between colorectal stricture and CRC, the investigators noted.
“Given the recent evidence on the risk of cancer associated with colonic strictures in CD, systematic colectomy is probably no longer justified,” they wrote. “Factors such as a long disease duration, primary sclerosing cholangitis, a history of dysplasia, and nonpassable and/or symptomatic stricture despite endoscopic dilation tend to argue in favor of surgery — especially if limited resection is possible.”
In contrast, patients with strictures who have low risk of CRC may be better served by a conservative approach, including endoscopy and systematic biopsies, followed by close endoscopic surveillance, according to the investigators. If the stricture is impassable, they recommended endoscopic balloon dilation, followed by intensification of medical therapy if ulceration is observed.
The investigators disclosed relationships with MSD, Ferring, Biogen, and others.
FROM GASTRO HEP ADVANCES
Five Key Measures to Ensure a Quality Colonoscopy
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
, a list that, for the first time, includes adequate bowel preparation and sessile serrated lesion detection rate (SSLDR).
“Endoscopy teams now have an updated set of guidelines which can be used to enhance the quality of their colonoscopies and should certainly use these current quality measures to ‘raise the bar’ on behalf of their patients,” task force member Nicholas J. Shaheen, MD, MPH, Division of Gastroenterology and Hepatology, The University of North Carolina at Chapel Hill, said in a statement.
The task force published the recommendations online August 21 in The American Journal of Gastroenterology and in Gastrointestinal Endoscopy. It represents the third iteration of the ACG/ASGE quality indicators on colonoscopy recommendations and incorporates new evidence published since 2015.
“The last set of quality indicators from this group was 9 years ago. Since then, there has been a tremendous amount of new data published in colonoscopy quality,” Ziad F. Gellad, MD, MPH, professor of medicine, Duke University Medical Center, Durham, North Carolina, said in an interview.
“Keeping up with that data is a challenge, and so guidelines such as these are important in helping clinicians synthesize data on quality of care and implement best practices,” said Dr. Gellad, who was not involved with the task force.
Two New Priority Indicators
The task force identified 15 quality indicators, divided into preprocedure, intraprocedure, and postprocedure. It includes five “priority” indicators — two of which are new.
One is the rate of adequate bowel preparation, preferably defined as a Boston Bowel Preparation Scale score ≥ 2 in each of three colon segments or by description of the preparation as excellent, good, or adequate. It has a performance target > 90%.
“Inadequate bowel preparation substantially increases the cost of colonoscopy delivery and creates risk and inconvenience for patients, thus warranting a ranking as a priority indicator,” the task force wrote.
Dr. Gellad explained that the addition of this priority indicator is “notable because it highlights the importance of bowel prep in high-quality colonoscopy. It also shifts more of the responsibility of bowel prep from the patient to the practice.”
The second new quality indicator is the SSLDR, which was selected due to its ability to contribute to cancer prevention.
Based on available evidence, the task force recommends a current minimum threshold for the SSLDR of 6%. “This is expected to be revised upward as evidence of increasing detection occurs,” they wrote.
Dr. Gellad said the addition of SSLDR is “an important advance in these recommendations. We know that serrated adenomas are a precursor for colorectal cancer and that the detection of these subtle lesions is variable.
“Providing a benchmark encourages practices to measure the detection of serrated adenomas and intervene when rates are below benchmarks. Prior to these benchmarks, it was difficult to know where to peg our expectations,” Dr. Gellad added.
Changes to the Adenoma Detection Rate (ADR)
The ADR remains a priority indicator in the update, albeit with changes.
To keep the ADR measurement consistent with current screening guidelines, the task force now recommends that the ADR be measured starting at age 45 rather than 50 years.
“ADR plays a critical role in evaluating the performance of the colonoscopists,” task force lead Douglas K. Rex, MD, a gastroenterologist at Indiana University School of Medicine in Indianapolis, said in the statement.
“It is recommended that ADR calculations include screening, surveillance, and diagnostic colonoscopy but exclude indications of a positive noncolonoscopy screening test and therapeutic procedures for resection or treatment of known neoplasia, genetic cancer syndromes, and inflammatory bowel disease,” Dr. Rex explained.
The task force recommends a minimum ADR threshold of 35% (40% in men and 30% in women) and that colonoscopists with ADRs below 35% “undertake remedial measures to improve and to achieve acceptable performance.”
Additional Priorities
The cecal intubation rate (CIR) — the percentage of patients undergoing colonoscopy with intact colons who have full intubation of the cecum with photo documentation of cecal landmarks — remains a priority quality indicator and has a performance target ≥ 95%.
“A trained colonoscopist should achieve a high CIR with a very high level of safety,” the task force wrote. “Low CIRs have been associated with higher PCCRC [postcolonoscopy colorectal cancer] rates.”
The final priority indicator is the rate of using recommended screening and surveillance intervals, which carries a performance target ≥ 90%.
“We recommend that quality improvement efforts initially focus on high-priority indicators and then progress to other indicators once it is ascertained that endoscopists are performing above recommended thresholds, either at baseline or after corrective interventions,” the task force wrote.
“The priority indicators are absolutely important for practices to implement,” Dr. Gellad said.
“There is compelling evidence that these measures are correlated with clinically important outcomes, particularly ADR,” he added. “Many practices already capture this data, and the changes in ADR calculation make measurement less burdensome. Hopefully, this will encourage more practices to collect and report these measures.”
Dr. Rex is a consultant for Olympus, Boston Scientific, Braintree Laboratories, Norgine, GI Supply, Medtronic, and Acacia Pharmaceuticals; receives research support from Olympus, Medivators, Erbe USA, and Braintree Laboratories; and is a shareholder in Satisfai Health. Dr. Shaheen had no relevant disclosures. Dr. Gellad has consulted for Merck & Co. and Novo Nordisk and is a cofounder of Higgs Boson.
A version of this article first appeared on Medscape.com.
Cold Snare Resection Safe for Large Nonpedunculated Colorectal Polyps
In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.
“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”
The researchers noted that while hot snare resection is the gold standard for larger nonpedunculated polyps of ≥ 2 cm, previous research has found the cold technique, which resects without cutting and cauterizing current, to be superior for small polyps .
“Our study suggests that sessile serrated lesions larger than 2 cm should be resected with the cold snare. Selected cases of lateral spreading tumors may also be good candidates for cold snare resection when safety concerns are paramount,” Dr. Steinbrück said in an interview. “Cold snare resection is standard of care in our center in these cases, but our data show no superiority over hot snare in terms of resection speed.”
Despite recommendations for its use, the cold snare method appears to be underused in the United States.
The Study
From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.
Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).
Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.
Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.
Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).
Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.
“Interestingly, near identical results were found in a recent report from a multicenter US trial presented at DDW earlier this year by Pohl et al., which adds credence to their findings,” he said. “While this study helps move the needle toward using cold EMR for large polyps, it also highlights an Achilles heel of this approach, a higher risk of residual polyps during follow-up.”
In other study findings, postpolypectomy syndrome occurred with similar frequency in both groups (3.1% vs 4.4%, P = .490).
As to the size factor, multivariable analysis revealed that a lesion diameter of at least 4 cm was an independent predictor of major AEs (OR, 3.37), residual adenoma (OR, 2.47), and high-grade dysplasia/cancer for residual adenoma (OR, 2.92).
In the case of suspected sessile serrated lesions, the rate of residual neoplasia was 8.3% (n = 4 of 48; 95% CI, 3.3-19.5) in the cold group and 4.8% (n = 2 of 42; 95% CI, 1.3-15.8) in the hot group (P = .681).
As for laterally spreading tumors (LSTs), Dr. Steinbrück said, “The higher recurrence rate after cold snare resection of LST nodular mixed types is unacceptable, and therefore, hot snare EMR with margin coagulation should be the treatment of choice.
“For LST granular type homogeneous and LST nongranular type without suspicion of malignancy, cold snare EMR with additional measures such as margin coagulation may be an option in selected cases — for example, when the risk of delayed bleeding is high,” he said.
Implications
This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.
Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”
The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.
“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”
This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.
A version of this article appeared on Medscape.com.
In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.
“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”
The researchers noted that while hot snare resection is the gold standard for larger nonpedunculated polyps of ≥ 2 cm, previous research has found the cold technique, which resects without cutting and cauterizing current, to be superior for small polyps .
“Our study suggests that sessile serrated lesions larger than 2 cm should be resected with the cold snare. Selected cases of lateral spreading tumors may also be good candidates for cold snare resection when safety concerns are paramount,” Dr. Steinbrück said in an interview. “Cold snare resection is standard of care in our center in these cases, but our data show no superiority over hot snare in terms of resection speed.”
Despite recommendations for its use, the cold snare method appears to be underused in the United States.
The Study
From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.
Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).
Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.
Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.
Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).
Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.
“Interestingly, near identical results were found in a recent report from a multicenter US trial presented at DDW earlier this year by Pohl et al., which adds credence to their findings,” he said. “While this study helps move the needle toward using cold EMR for large polyps, it also highlights an Achilles heel of this approach, a higher risk of residual polyps during follow-up.”
In other study findings, postpolypectomy syndrome occurred with similar frequency in both groups (3.1% vs 4.4%, P = .490).
As to the size factor, multivariable analysis revealed that a lesion diameter of at least 4 cm was an independent predictor of major AEs (OR, 3.37), residual adenoma (OR, 2.47), and high-grade dysplasia/cancer for residual adenoma (OR, 2.92).
In the case of suspected sessile serrated lesions, the rate of residual neoplasia was 8.3% (n = 4 of 48; 95% CI, 3.3-19.5) in the cold group and 4.8% (n = 2 of 42; 95% CI, 1.3-15.8) in the hot group (P = .681).
As for laterally spreading tumors (LSTs), Dr. Steinbrück said, “The higher recurrence rate after cold snare resection of LST nodular mixed types is unacceptable, and therefore, hot snare EMR with margin coagulation should be the treatment of choice.
“For LST granular type homogeneous and LST nongranular type without suspicion of malignancy, cold snare EMR with additional measures such as margin coagulation may be an option in selected cases — for example, when the risk of delayed bleeding is high,” he said.
Implications
This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.
Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”
The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.
“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”
This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.
A version of this article appeared on Medscape.com.
In findings from Germany’s randomized controlled CHRONICLE trial, published in Gastroenterology , the cold technique almost eliminated major adverse events (AEs) — but at the cost of higher rates of recurrence and residual adenoma at first follow-up.
“The exact definition of the ideal lesions requires further research,” wrote investigators led by Ingo Steinbrück, MD, of the Department of Medicine and Gastroenterology at the Academic Teaching Hospital of the University of Freiburg, Freiburg im Breisgau, Germany. “Further studies have to confirm to what extent polyp size and histology can determine an individualized approach.”
The researchers noted that while hot snare resection is the gold standard for larger nonpedunculated polyps of ≥ 2 cm, previous research has found the cold technique, which resects without cutting and cauterizing current, to be superior for small polyps .
“Our study suggests that sessile serrated lesions larger than 2 cm should be resected with the cold snare. Selected cases of lateral spreading tumors may also be good candidates for cold snare resection when safety concerns are paramount,” Dr. Steinbrück said in an interview. “Cold snare resection is standard of care in our center in these cases, but our data show no superiority over hot snare in terms of resection speed.”
Despite recommendations for its use, the cold snare method appears to be underused in the United States.
The Study
From June 2021 to July 2023, the 19-center intention-to-treat analysis enrolled 363 patients (48.2% women) with a total of 396 polyps and randomly assigned those with polyps of ≥ 20 mm to cold (n = 193) or hot EMR (n = 203). The primary outcome was major AEs such as perforation or post-endoscopic bleeding.
Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001, odds ratio [OR], 0.12; 95% CI, 0.03-0.54).
Rates for perforation and post-endoscopic bleeding were significantly lower in the cold group, with 0 vs 8 (0% vs 3.9%, P = .007) perforations in the two groups, respectively, as well as 1.0% vs 4.4% (P = .040) for postprocedural bleeding.
Somewhat surprisingly, intraprocedural bleeding was also less common in the cold EMR group at 14% vs 23%.
Residual adenoma, however, was found more frequently in the cold group at 23.7% vs 13.8% (OR, 1.94; 95% CI,1.12-3.38; P = .020).
Commenting on the study but not involved in it, Seth Crockett, MD, MPH, AGAF, a professor of medicine in the Division of Gastroenterology and Hepatology at Oregon Health & Science University in Portland, Oregon, called the CHRONICLE findings very important.
“Interestingly, near identical results were found in a recent report from a multicenter US trial presented at DDW earlier this year by Pohl et al., which adds credence to their findings,” he said. “While this study helps move the needle toward using cold EMR for large polyps, it also highlights an Achilles heel of this approach, a higher risk of residual polyps during follow-up.”
In other study findings, postpolypectomy syndrome occurred with similar frequency in both groups (3.1% vs 4.4%, P = .490).
As to the size factor, multivariable analysis revealed that a lesion diameter of at least 4 cm was an independent predictor of major AEs (OR, 3.37), residual adenoma (OR, 2.47), and high-grade dysplasia/cancer for residual adenoma (OR, 2.92).
In the case of suspected sessile serrated lesions, the rate of residual neoplasia was 8.3% (n = 4 of 48; 95% CI, 3.3-19.5) in the cold group and 4.8% (n = 2 of 42; 95% CI, 1.3-15.8) in the hot group (P = .681).
As for laterally spreading tumors (LSTs), Dr. Steinbrück said, “The higher recurrence rate after cold snare resection of LST nodular mixed types is unacceptable, and therefore, hot snare EMR with margin coagulation should be the treatment of choice.
“For LST granular type homogeneous and LST nongranular type without suspicion of malignancy, cold snare EMR with additional measures such as margin coagulation may be an option in selected cases — for example, when the risk of delayed bleeding is high,” he said.
Implications
This study has several implications, Dr. Crockett said. First, more research and innovation are needed to develop techniques to maximize complete resection during cold EMR and minimize residual polyp rates. “Ideally, this would involve other cold techniques so as not to offset the safety benefits of cold EMR,” he noted.
Second, patient selection is important, as cold EMR is likely more suitable for those with serrated lesions and for those in whom follow-up can be assured, he added. “For patients who have the largest polyps, particularly lesions of the laterally spreading tumor, nodular mixed type, and those who do not wish to participate in surveillance, hot EMR may be preferable, at least at this point.”
The authors agreed that new technical development that improves the outcomes and cost-effectiveness of cold snare polypectomy and combines its demonstrated safety with recurrence reduction is necessary, as are studies to identify optimal candidate lesions.
“The next step is to evaluate whether cold snare EMR with additional measures leads to a recurrence rate comparable to hot snare EMR with margin coagulation,” Dr. Steinbrück said. “If this is the case, cold snare resection may be the future treatment of choice for all large nonpedunculated polyps without suspected malignancy in the colorectum.”
This work was supported by the Gastroenterology Foundation, Küsnacht, Switzerland. Dr. Steinbrück reported lecture fees and travel grants from Olympus Medical, a polypectomy device maker, and Falk Pharma. Numerous coauthors disclosed financial relationships with pharmaceutical and medical device companies, including Olympus Medical. Dr. Crockett disclosed no competing interests relevant to his comments.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Stool-Based Methylation Test May Improve CRC Screening
based on a prospective, real-world study.
These findings suggest that the mSDC2 assay could improve the efficacy and resource utilization of existing screening programs, reported co–lead authors Shengbing Zhao, MD and Zixuan He, MD, of Naval Medical University, Shanghai, China, and colleagues.
“Conventional risk-stratification strategies, such as fecal immunochemical test (FIT) and life risk factors, are still criticized for being inferior at identifying early-stage CRC and ACN, and their real-world performance is probably further weakened by the low annual participation rate and compliance of subsequent colonoscopy,” the investigators wrote in Gastroenterology. Recent case studies have reported “high diagnostic performance” using stool-based testing for mSDC2, which is “the most accurate single-targeted gene” for colorectal neoplasia, according to the investigators; however, real-world outcomes have yet to be demonstrated, prompting the present study. The prospective, multicenter, community-based trial compared the diagnostic performance of the mSDC2 test against FIT and Asia-Pacific Colorectal Screening (APCS) scores.
The primary outcome was detection of ACN. Secondary outcomes included detection of CRC, early-stage CRC, ACN, colorectal neoplasia (CN), and clinically relevant serrated polyp (CRSP). Screening strategies were also compared in terms of cost-effectiveness and impact on colonoscopy workload.The final dataset included 10,360 participants aged 45-75 years who underwent screening between 2020 and 2022.
After determining APCS scores, stool samples were analyzed for mSDC2 and FIT markers. Based on risk stratification results, participants were invited to undergo colonoscopy. A total of 3,381 participants completed colonoscopy, with 1914 from the increased-risk population and 1467 from the average-risk population. Participants who tested positive for mSDC2 had significantly higher detection rates for all measured outcomes than those who tested negative (all, P < .05). For example, the detection rate for ACN was 26.6% in mSDC2-positive participants, compared with 9.3% in mSDC2-negative participants, with a relative risk of 2.87 (95% CI, 2.39-3.44). For CRC, the detection rate was 4.2% in mSDC2-positive participants vs 0.1% in mSDC2-negative participants, yielding a relative risk of 29.73 (95% CI, 10.29-85.91). Performance held steady across subgroups.The mSDC2 test demonstrated cost-effectiveness by significantly reducing the number of colonoscopies needed to detect one case of ACN or CRC. Specifically, the number of colonoscopies needed to screen for ACN and CRC was reduced by 56.2% and 81.5%, respectively. Parallel combinations of mSDC2 with APCS or FIT enhanced both diagnostic performance and cost-effectiveness.
“This study further illustrates that the mSDC2 test consistently improves predictive abilities for CN, CRSP, ACN, and CRC, which is not influenced by subgroups of lesion location or risk factors, even under the risk stratification by FIT or APCS,” the investigators wrote. “The excellent diagnostic ability of mSDC2 in premalignant lesions, early-stage CRC, and early-onset CRC indicates a promising value in early detection and prevention of CRC ... the mSDC2 test or a parallel combination of multiple screening methods might be promising to improve real-world CRC screening performance and reduce colonoscopy workload in community practice.”The study was supported by the National Key Research and Development Program of China, Deep Blue Project of Naval Medical University, the Creative Biosciences, and others. The investigators reported no conflicts of interest.
based on a prospective, real-world study.
These findings suggest that the mSDC2 assay could improve the efficacy and resource utilization of existing screening programs, reported co–lead authors Shengbing Zhao, MD and Zixuan He, MD, of Naval Medical University, Shanghai, China, and colleagues.
“Conventional risk-stratification strategies, such as fecal immunochemical test (FIT) and life risk factors, are still criticized for being inferior at identifying early-stage CRC and ACN, and their real-world performance is probably further weakened by the low annual participation rate and compliance of subsequent colonoscopy,” the investigators wrote in Gastroenterology. Recent case studies have reported “high diagnostic performance” using stool-based testing for mSDC2, which is “the most accurate single-targeted gene” for colorectal neoplasia, according to the investigators; however, real-world outcomes have yet to be demonstrated, prompting the present study. The prospective, multicenter, community-based trial compared the diagnostic performance of the mSDC2 test against FIT and Asia-Pacific Colorectal Screening (APCS) scores.
The primary outcome was detection of ACN. Secondary outcomes included detection of CRC, early-stage CRC, ACN, colorectal neoplasia (CN), and clinically relevant serrated polyp (CRSP). Screening strategies were also compared in terms of cost-effectiveness and impact on colonoscopy workload.The final dataset included 10,360 participants aged 45-75 years who underwent screening between 2020 and 2022.
After determining APCS scores, stool samples were analyzed for mSDC2 and FIT markers. Based on risk stratification results, participants were invited to undergo colonoscopy. A total of 3,381 participants completed colonoscopy, with 1914 from the increased-risk population and 1467 from the average-risk population. Participants who tested positive for mSDC2 had significantly higher detection rates for all measured outcomes than those who tested negative (all, P < .05). For example, the detection rate for ACN was 26.6% in mSDC2-positive participants, compared with 9.3% in mSDC2-negative participants, with a relative risk of 2.87 (95% CI, 2.39-3.44). For CRC, the detection rate was 4.2% in mSDC2-positive participants vs 0.1% in mSDC2-negative participants, yielding a relative risk of 29.73 (95% CI, 10.29-85.91). Performance held steady across subgroups.The mSDC2 test demonstrated cost-effectiveness by significantly reducing the number of colonoscopies needed to detect one case of ACN or CRC. Specifically, the number of colonoscopies needed to screen for ACN and CRC was reduced by 56.2% and 81.5%, respectively. Parallel combinations of mSDC2 with APCS or FIT enhanced both diagnostic performance and cost-effectiveness.
“This study further illustrates that the mSDC2 test consistently improves predictive abilities for CN, CRSP, ACN, and CRC, which is not influenced by subgroups of lesion location or risk factors, even under the risk stratification by FIT or APCS,” the investigators wrote. “The excellent diagnostic ability of mSDC2 in premalignant lesions, early-stage CRC, and early-onset CRC indicates a promising value in early detection and prevention of CRC ... the mSDC2 test or a parallel combination of multiple screening methods might be promising to improve real-world CRC screening performance and reduce colonoscopy workload in community practice.”The study was supported by the National Key Research and Development Program of China, Deep Blue Project of Naval Medical University, the Creative Biosciences, and others. The investigators reported no conflicts of interest.
based on a prospective, real-world study.
These findings suggest that the mSDC2 assay could improve the efficacy and resource utilization of existing screening programs, reported co–lead authors Shengbing Zhao, MD and Zixuan He, MD, of Naval Medical University, Shanghai, China, and colleagues.
“Conventional risk-stratification strategies, such as fecal immunochemical test (FIT) and life risk factors, are still criticized for being inferior at identifying early-stage CRC and ACN, and their real-world performance is probably further weakened by the low annual participation rate and compliance of subsequent colonoscopy,” the investigators wrote in Gastroenterology. Recent case studies have reported “high diagnostic performance” using stool-based testing for mSDC2, which is “the most accurate single-targeted gene” for colorectal neoplasia, according to the investigators; however, real-world outcomes have yet to be demonstrated, prompting the present study. The prospective, multicenter, community-based trial compared the diagnostic performance of the mSDC2 test against FIT and Asia-Pacific Colorectal Screening (APCS) scores.
The primary outcome was detection of ACN. Secondary outcomes included detection of CRC, early-stage CRC, ACN, colorectal neoplasia (CN), and clinically relevant serrated polyp (CRSP). Screening strategies were also compared in terms of cost-effectiveness and impact on colonoscopy workload.The final dataset included 10,360 participants aged 45-75 years who underwent screening between 2020 and 2022.
After determining APCS scores, stool samples were analyzed for mSDC2 and FIT markers. Based on risk stratification results, participants were invited to undergo colonoscopy. A total of 3,381 participants completed colonoscopy, with 1914 from the increased-risk population and 1467 from the average-risk population. Participants who tested positive for mSDC2 had significantly higher detection rates for all measured outcomes than those who tested negative (all, P < .05). For example, the detection rate for ACN was 26.6% in mSDC2-positive participants, compared with 9.3% in mSDC2-negative participants, with a relative risk of 2.87 (95% CI, 2.39-3.44). For CRC, the detection rate was 4.2% in mSDC2-positive participants vs 0.1% in mSDC2-negative participants, yielding a relative risk of 29.73 (95% CI, 10.29-85.91). Performance held steady across subgroups.The mSDC2 test demonstrated cost-effectiveness by significantly reducing the number of colonoscopies needed to detect one case of ACN or CRC. Specifically, the number of colonoscopies needed to screen for ACN and CRC was reduced by 56.2% and 81.5%, respectively. Parallel combinations of mSDC2 with APCS or FIT enhanced both diagnostic performance and cost-effectiveness.
“This study further illustrates that the mSDC2 test consistently improves predictive abilities for CN, CRSP, ACN, and CRC, which is not influenced by subgroups of lesion location or risk factors, even under the risk stratification by FIT or APCS,” the investigators wrote. “The excellent diagnostic ability of mSDC2 in premalignant lesions, early-stage CRC, and early-onset CRC indicates a promising value in early detection and prevention of CRC ... the mSDC2 test or a parallel combination of multiple screening methods might be promising to improve real-world CRC screening performance and reduce colonoscopy workload in community practice.”The study was supported by the National Key Research and Development Program of China, Deep Blue Project of Naval Medical University, the Creative Biosciences, and others. The investigators reported no conflicts of interest.
FROM GASTROENTEROLOGY
FDA Approves First Blood Test for Colorectal Cancer
In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.
While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.
“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.
Five Key Takeaways
- A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
- A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
- Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
- Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
- Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.
“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.
In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.
While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.
“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.
Five Key Takeaways
- A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
- A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
- Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
- Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
- Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.
“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.
In late July, the US Food and Drug Administration (FDA) approved the first use of a liquid biopsy (blood test) for colorectal cancer (CRC) screening. The test, called Shield, launched commercially the first week of August and is the first blood test to be approved by the FDA as a primary screening option for CRC that meets requirements for Medicare reimbursement.
While the convenience of a blood test could potentially encourage more people to get screened, expert consensus is that blood tests can’t prevent CRC and should not be considered a replacement for a colonoscopy. Modeling studies and expert consensus published earlier this year in Gastroenterology and in Clinical Gastroenterology and Hepatology shed light on the perils of liquid biopsy.
“Based on their current characteristics, blood tests should not be recommended to replace established colorectal cancer screening tests, since blood tests are neither as effective nor as cost-effective, and would worsen outcomes,” said David Lieberman, MD, AGAF, chair, AGA CRC Workshop chair and lead author of an expert commentary on liquid biopsy for CRC screening.
Five Key Takeaways
- A blood test for CRC that meets minimal CMS criteria for sensitivity and performed every 3 years would likely result in better outcomes than no screening.
- A blood test for CRC offers a simple process that could encourage more people to participate in screening. Patients who may have declined colonoscopy should understand the need for a colonoscopy if findings are abnormal.
- Because blood tests for CRC are predicted to be less effective and more costly than currently established screening programs, they cannot be recommended to replace established effective screening methods.
- Although blood tests would improve outcomes in currently unscreened people, substituting blood tests for a currently effective test would worsen patient outcomes and increase cost.
- Potential benchmarks that industry might use to assess an effective blood test for CRC going forward would be sensitivity for stage I-III CRC of > 90%, with sensitivity for advanced adenomas of > 40%-50%.
“Unless we have the expectation of high sensitivity and specificity, blood-based colorectal cancer tests could lead to false positive and false negative results, which are both bad for patient outcomes,” said John M. Carethers, MD, AGAF, AGA past president and vice chancellor for health sciences at the University of California San Diego.
August 2024 – ICYMI
Gastroenterology
April 2024
Shah I, et al. Disparities in Colorectal Cancer Screening Among Asian American Populations and Strategies to Address These Disparities. Gastroenterology. 2024 Apr;166(4):549-552. doi: 10.1053/j.gastro.2024.02.009. PMID: 38521575.
Shiha MG, et al. Accuracy of the No-Biopsy Approach for the Diagnosis of Celiac Disease in Adults: A Systematic Review and Meta-Analysis. Gastroenterology. 2024 Apr;166(4):620-630. doi: 10.1053/j.gastro.2023.12.023. Epub 2024 Jan 2. PMID: 38176661.
Goltstein LCMJ, et al. Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Apr;166(4):690-703. doi: 10.1053/j.gastro.2023.12.020. Epub 2023 Dec 28. PMID: 38158089.
May 2024
Robertson DJ, et al. Colonoscopy vs the Fecal Immunochemical Test: Which is Best? Gastroenterology. 2024 May;166(5):758-771. doi: 10.1053/j.gastro.2023.12.027. Epub 2024 Feb 9. PMID: 38342196.
Mårild K, et al. Histologic Remission in Inflammatory Bowel Disease and Female Fertility: A Nationwide Study. Gastroenterology. 2024 May;166(5):802-814.e18. doi: 10.1053/j.gastro.2024.01.018. Epub 2024 Feb 6. PMID: 38331202.
June 2024
Trivedi PJ, et al. Immunopathogenesis of Primary Biliary Cholangitis, Primary Sclerosing Cholangitis and Autoimmune Hepatitis: Themes and Concepts. Gastroenterology. 2024 Jun;166(6):995-1019. doi: 10.1053/j.gastro.2024.01.049. Epub 2024 Feb 10. PMID: 38342195.
Rubenstein JH, et al. AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett’s Esophagus and Related Neoplasia. Gastroenterology. 2024 Jun;166(6):1020-1055. doi: 10.1053/j.gastro.2024.03.019. PMID: 38763697.
Ridtitid W, et al. Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial. Gastroenterology. 2024 Jun;166(6):1145-1155. doi: 10.1053/j.gastro.2024.02.007. Epub 2024 Feb 14. PMID: 38360274.
Clinical Gastroenterology and Hepatology
April 2024
Berwald G, et al. The Diagnostic Performance of Fecal Immunochemical Tests for Detecting Advanced Neoplasia at Surveillance Colonoscopy. Clin Gastroenterol Hepatol. 2024 Apr;22(4):878-885.e2. doi: 10.1016/j.cgh.2023.09.016. Epub 2023 Sep 22. PMID: 37743036.
Hashash JG, et al. AGA Rapid Clinical Practice Update on the Management of Patients Taking GLP-1 Receptor Agonists Prior to Endoscopy: Communication. Clin Gastroenterol Hepatol. 2024 Apr;22(4):705-707. doi: 10.1016/j.cgh.2023.11.002. Epub 2023 Nov 7. PMID: 37944573.
Sharma R, et al. Statins Are Associated With a Decreased Risk of Severe Liver Disease in Individuals With Noncirrhotic Chronic Liver Disease. Clin Gastroenterol Hepatol. 2024 Apr;22(4):749-759.e19. doi: 10.1016/j.cgh.2023.04.017. Epub 2023 Apr 28. PMID: 37121528.
May 2024
Overbeek KA, et al; PrescrAIP Study Group. Type 1 Autoimmune Pancreatitis in Europe: Clinical Profile and Response to Treatment. Clin Gastroenterol Hepatol. 2024 May;22(5):994-1004.e10. doi: 10.1016/j.cgh.2023.12.010. Epub 2024 Jan 5. Erratum in: Clin Gastroenterol Hepatol. 2024 Jun 1:S1542-3565(24)00446-4. doi: 10.1016/j.cgh.2024.05.005. PMID: 38184096.
Jairath V, et al. ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse. Clin Gastroenterol Hepatol. 2024 May;22(5):1077-1086.e13. doi: 10.1016/j.cgh.2023.10.029. Epub 2023 Nov 10. PMID: 37951560.
Gunby SA, et al. Smoking and Alcohol Consumption and Risk of Incident Diverticulitis in Women. Clin Gastroenterol Hepatol. 2024 May;22(5):1108-1116. doi: 10.1016/j.cgh.2023.11.036. Epub 2023 Dec 19. PMID: 38122959; PMCID: PMC11045313.
June 2024
Krause AJ, et al. Validated Clinical Score to Predict Gastroesophageal Reflux in Patients With Chronic Laryngeal Symptoms: COuGH RefluX. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1200-1209.e1. doi: 10.1016/j.cgh.2024.01.021. Epub 2024 Feb 2. PMID: 38309491; PMCID: PMC11128352.
Peng X, et al. Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1210-1216. doi: 10.1016/j.cgh.2024.01.022. Epub 2024 Feb 1. PMID: 38309492.
Kedia S, et al. Coconut Water Induces Clinical Remission in Mild to Moderate Ulcerative Colitis: Double-blind Placebo-controlled Trial. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1295-1306.e7. doi: 10.1016/j.cgh.2024.01.013. Epub 2024 Jan 24. PMID: 38278200.
Techniques and Innovations in Gastrointestinal Endoscopy
Ogura T, et al. Step-Up Strategy for Endoscopic Hemostasis Using PuraStat After Endoscopic Sphincterotomy Bleeding (STOP Trial). Tech Innov Gastrointest Endosc. 2024 March 16. doi: 10.1016/j.tige.2024.03.005.
Nakai Y, et al. Cyst Detection Rate: A Quality Indicator in the Era of Pancreatic Screening Endoscopic Ultrasonography. Tech Innov Gastrointest Endosc. 2024 May. doi: 10.1016/j.tige.2024.04.001.
Gastro Hep Advances
Kimura Y, et al. Early Sonographic Improvement Predicts Clinical Remission and Mucosal Healing With Molecular-Targeted Drugs in Ulcerative Colitis. Gastro Hep Adv. 2024 April 22. doi: 10.1016/j.gastha.2024.04.007.
Hunaut T, et al. Long-Term Neoplastic Risk Associated With Colorectal Strictures in Crohn’s Disease: A Multicenter Study. Gastro Hep Adv. 2024 May 15. doi: 10.1016/j.gastha.2024.05.003.
Gastroenterology
April 2024
Shah I, et al. Disparities in Colorectal Cancer Screening Among Asian American Populations and Strategies to Address These Disparities. Gastroenterology. 2024 Apr;166(4):549-552. doi: 10.1053/j.gastro.2024.02.009. PMID: 38521575.
Shiha MG, et al. Accuracy of the No-Biopsy Approach for the Diagnosis of Celiac Disease in Adults: A Systematic Review and Meta-Analysis. Gastroenterology. 2024 Apr;166(4):620-630. doi: 10.1053/j.gastro.2023.12.023. Epub 2024 Jan 2. PMID: 38176661.
Goltstein LCMJ, et al. Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Apr;166(4):690-703. doi: 10.1053/j.gastro.2023.12.020. Epub 2023 Dec 28. PMID: 38158089.
May 2024
Robertson DJ, et al. Colonoscopy vs the Fecal Immunochemical Test: Which is Best? Gastroenterology. 2024 May;166(5):758-771. doi: 10.1053/j.gastro.2023.12.027. Epub 2024 Feb 9. PMID: 38342196.
Mårild K, et al. Histologic Remission in Inflammatory Bowel Disease and Female Fertility: A Nationwide Study. Gastroenterology. 2024 May;166(5):802-814.e18. doi: 10.1053/j.gastro.2024.01.018. Epub 2024 Feb 6. PMID: 38331202.
June 2024
Trivedi PJ, et al. Immunopathogenesis of Primary Biliary Cholangitis, Primary Sclerosing Cholangitis and Autoimmune Hepatitis: Themes and Concepts. Gastroenterology. 2024 Jun;166(6):995-1019. doi: 10.1053/j.gastro.2024.01.049. Epub 2024 Feb 10. PMID: 38342195.
Rubenstein JH, et al. AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett’s Esophagus and Related Neoplasia. Gastroenterology. 2024 Jun;166(6):1020-1055. doi: 10.1053/j.gastro.2024.03.019. PMID: 38763697.
Ridtitid W, et al. Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial. Gastroenterology. 2024 Jun;166(6):1145-1155. doi: 10.1053/j.gastro.2024.02.007. Epub 2024 Feb 14. PMID: 38360274.
Clinical Gastroenterology and Hepatology
April 2024
Berwald G, et al. The Diagnostic Performance of Fecal Immunochemical Tests for Detecting Advanced Neoplasia at Surveillance Colonoscopy. Clin Gastroenterol Hepatol. 2024 Apr;22(4):878-885.e2. doi: 10.1016/j.cgh.2023.09.016. Epub 2023 Sep 22. PMID: 37743036.
Hashash JG, et al. AGA Rapid Clinical Practice Update on the Management of Patients Taking GLP-1 Receptor Agonists Prior to Endoscopy: Communication. Clin Gastroenterol Hepatol. 2024 Apr;22(4):705-707. doi: 10.1016/j.cgh.2023.11.002. Epub 2023 Nov 7. PMID: 37944573.
Sharma R, et al. Statins Are Associated With a Decreased Risk of Severe Liver Disease in Individuals With Noncirrhotic Chronic Liver Disease. Clin Gastroenterol Hepatol. 2024 Apr;22(4):749-759.e19. doi: 10.1016/j.cgh.2023.04.017. Epub 2023 Apr 28. PMID: 37121528.
May 2024
Overbeek KA, et al; PrescrAIP Study Group. Type 1 Autoimmune Pancreatitis in Europe: Clinical Profile and Response to Treatment. Clin Gastroenterol Hepatol. 2024 May;22(5):994-1004.e10. doi: 10.1016/j.cgh.2023.12.010. Epub 2024 Jan 5. Erratum in: Clin Gastroenterol Hepatol. 2024 Jun 1:S1542-3565(24)00446-4. doi: 10.1016/j.cgh.2024.05.005. PMID: 38184096.
Jairath V, et al. ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse. Clin Gastroenterol Hepatol. 2024 May;22(5):1077-1086.e13. doi: 10.1016/j.cgh.2023.10.029. Epub 2023 Nov 10. PMID: 37951560.
Gunby SA, et al. Smoking and Alcohol Consumption and Risk of Incident Diverticulitis in Women. Clin Gastroenterol Hepatol. 2024 May;22(5):1108-1116. doi: 10.1016/j.cgh.2023.11.036. Epub 2023 Dec 19. PMID: 38122959; PMCID: PMC11045313.
June 2024
Krause AJ, et al. Validated Clinical Score to Predict Gastroesophageal Reflux in Patients With Chronic Laryngeal Symptoms: COuGH RefluX. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1200-1209.e1. doi: 10.1016/j.cgh.2024.01.021. Epub 2024 Feb 2. PMID: 38309491; PMCID: PMC11128352.
Peng X, et al. Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1210-1216. doi: 10.1016/j.cgh.2024.01.022. Epub 2024 Feb 1. PMID: 38309492.
Kedia S, et al. Coconut Water Induces Clinical Remission in Mild to Moderate Ulcerative Colitis: Double-blind Placebo-controlled Trial. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1295-1306.e7. doi: 10.1016/j.cgh.2024.01.013. Epub 2024 Jan 24. PMID: 38278200.
Techniques and Innovations in Gastrointestinal Endoscopy
Ogura T, et al. Step-Up Strategy for Endoscopic Hemostasis Using PuraStat After Endoscopic Sphincterotomy Bleeding (STOP Trial). Tech Innov Gastrointest Endosc. 2024 March 16. doi: 10.1016/j.tige.2024.03.005.
Nakai Y, et al. Cyst Detection Rate: A Quality Indicator in the Era of Pancreatic Screening Endoscopic Ultrasonography. Tech Innov Gastrointest Endosc. 2024 May. doi: 10.1016/j.tige.2024.04.001.
Gastro Hep Advances
Kimura Y, et al. Early Sonographic Improvement Predicts Clinical Remission and Mucosal Healing With Molecular-Targeted Drugs in Ulcerative Colitis. Gastro Hep Adv. 2024 April 22. doi: 10.1016/j.gastha.2024.04.007.
Hunaut T, et al. Long-Term Neoplastic Risk Associated With Colorectal Strictures in Crohn’s Disease: A Multicenter Study. Gastro Hep Adv. 2024 May 15. doi: 10.1016/j.gastha.2024.05.003.
Gastroenterology
April 2024
Shah I, et al. Disparities in Colorectal Cancer Screening Among Asian American Populations and Strategies to Address These Disparities. Gastroenterology. 2024 Apr;166(4):549-552. doi: 10.1053/j.gastro.2024.02.009. PMID: 38521575.
Shiha MG, et al. Accuracy of the No-Biopsy Approach for the Diagnosis of Celiac Disease in Adults: A Systematic Review and Meta-Analysis. Gastroenterology. 2024 Apr;166(4):620-630. doi: 10.1053/j.gastro.2023.12.023. Epub 2024 Jan 2. PMID: 38176661.
Goltstein LCMJ, et al. Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Apr;166(4):690-703. doi: 10.1053/j.gastro.2023.12.020. Epub 2023 Dec 28. PMID: 38158089.
May 2024
Robertson DJ, et al. Colonoscopy vs the Fecal Immunochemical Test: Which is Best? Gastroenterology. 2024 May;166(5):758-771. doi: 10.1053/j.gastro.2023.12.027. Epub 2024 Feb 9. PMID: 38342196.
Mårild K, et al. Histologic Remission in Inflammatory Bowel Disease and Female Fertility: A Nationwide Study. Gastroenterology. 2024 May;166(5):802-814.e18. doi: 10.1053/j.gastro.2024.01.018. Epub 2024 Feb 6. PMID: 38331202.
June 2024
Trivedi PJ, et al. Immunopathogenesis of Primary Biliary Cholangitis, Primary Sclerosing Cholangitis and Autoimmune Hepatitis: Themes and Concepts. Gastroenterology. 2024 Jun;166(6):995-1019. doi: 10.1053/j.gastro.2024.01.049. Epub 2024 Feb 10. PMID: 38342195.
Rubenstein JH, et al. AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett’s Esophagus and Related Neoplasia. Gastroenterology. 2024 Jun;166(6):1020-1055. doi: 10.1053/j.gastro.2024.03.019. PMID: 38763697.
Ridtitid W, et al. Endoscopic Gallbladder Stenting to Prevent Recurrent Cholecystitis in Deferred Cholecystectomy: A Randomized Trial. Gastroenterology. 2024 Jun;166(6):1145-1155. doi: 10.1053/j.gastro.2024.02.007. Epub 2024 Feb 14. PMID: 38360274.
Clinical Gastroenterology and Hepatology
April 2024
Berwald G, et al. The Diagnostic Performance of Fecal Immunochemical Tests for Detecting Advanced Neoplasia at Surveillance Colonoscopy. Clin Gastroenterol Hepatol. 2024 Apr;22(4):878-885.e2. doi: 10.1016/j.cgh.2023.09.016. Epub 2023 Sep 22. PMID: 37743036.
Hashash JG, et al. AGA Rapid Clinical Practice Update on the Management of Patients Taking GLP-1 Receptor Agonists Prior to Endoscopy: Communication. Clin Gastroenterol Hepatol. 2024 Apr;22(4):705-707. doi: 10.1016/j.cgh.2023.11.002. Epub 2023 Nov 7. PMID: 37944573.
Sharma R, et al. Statins Are Associated With a Decreased Risk of Severe Liver Disease in Individuals With Noncirrhotic Chronic Liver Disease. Clin Gastroenterol Hepatol. 2024 Apr;22(4):749-759.e19. doi: 10.1016/j.cgh.2023.04.017. Epub 2023 Apr 28. PMID: 37121528.
May 2024
Overbeek KA, et al; PrescrAIP Study Group. Type 1 Autoimmune Pancreatitis in Europe: Clinical Profile and Response to Treatment. Clin Gastroenterol Hepatol. 2024 May;22(5):994-1004.e10. doi: 10.1016/j.cgh.2023.12.010. Epub 2024 Jan 5. Erratum in: Clin Gastroenterol Hepatol. 2024 Jun 1:S1542-3565(24)00446-4. doi: 10.1016/j.cgh.2024.05.005. PMID: 38184096.
Jairath V, et al. ENTERPRET: A Randomized Controlled Trial of Vedolizumab Dose Optimization in Patients With Ulcerative Colitis Who Have Early Nonresponse. Clin Gastroenterol Hepatol. 2024 May;22(5):1077-1086.e13. doi: 10.1016/j.cgh.2023.10.029. Epub 2023 Nov 10. PMID: 37951560.
Gunby SA, et al. Smoking and Alcohol Consumption and Risk of Incident Diverticulitis in Women. Clin Gastroenterol Hepatol. 2024 May;22(5):1108-1116. doi: 10.1016/j.cgh.2023.11.036. Epub 2023 Dec 19. PMID: 38122959; PMCID: PMC11045313.
June 2024
Krause AJ, et al. Validated Clinical Score to Predict Gastroesophageal Reflux in Patients With Chronic Laryngeal Symptoms: COuGH RefluX. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1200-1209.e1. doi: 10.1016/j.cgh.2024.01.021. Epub 2024 Feb 2. PMID: 38309491; PMCID: PMC11128352.
Peng X, et al. Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1210-1216. doi: 10.1016/j.cgh.2024.01.022. Epub 2024 Feb 1. PMID: 38309492.
Kedia S, et al. Coconut Water Induces Clinical Remission in Mild to Moderate Ulcerative Colitis: Double-blind Placebo-controlled Trial. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1295-1306.e7. doi: 10.1016/j.cgh.2024.01.013. Epub 2024 Jan 24. PMID: 38278200.
Techniques and Innovations in Gastrointestinal Endoscopy
Ogura T, et al. Step-Up Strategy for Endoscopic Hemostasis Using PuraStat After Endoscopic Sphincterotomy Bleeding (STOP Trial). Tech Innov Gastrointest Endosc. 2024 March 16. doi: 10.1016/j.tige.2024.03.005.
Nakai Y, et al. Cyst Detection Rate: A Quality Indicator in the Era of Pancreatic Screening Endoscopic Ultrasonography. Tech Innov Gastrointest Endosc. 2024 May. doi: 10.1016/j.tige.2024.04.001.
Gastro Hep Advances
Kimura Y, et al. Early Sonographic Improvement Predicts Clinical Remission and Mucosal Healing With Molecular-Targeted Drugs in Ulcerative Colitis. Gastro Hep Adv. 2024 April 22. doi: 10.1016/j.gastha.2024.04.007.
Hunaut T, et al. Long-Term Neoplastic Risk Associated With Colorectal Strictures in Crohn’s Disease: A Multicenter Study. Gastro Hep Adv. 2024 May 15. doi: 10.1016/j.gastha.2024.05.003.