Upper GI Tract

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TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Healthier sleep is associated with lower odds of developing a wide range of gastrointestinal conditions, regardless of genetic susceptibility, new research revealed.

METHODOLOGY:

• Due to the widespread prevalence of sleep issues and a growing burden of digestive diseases globally, researchers investigated the association between sleep quality and digestive disorders in a prospective cohort study of 410,586 people in the UK Biobank.
• Five individual sleep behaviors were assessed: sleep duration, insomnia, snoring, daytime sleepiness, and chronotype.
• A healthy sleep was defined as a morning chronotype, 7-8 hours of sleep duration, no self-reported snoring, never or rare insomnia, and a low frequency of daytime sleepiness, for a score of 5/5.
• The study investigators tracked the development of 16 digestive diseases over a mean period of 13.2 years.
• As well as looking at healthy sleep scores, researchers considered genetic susceptibility to gastrointestinal conditions.

TAKEAWAY:

• Participants with a healthy sleep score had 28% lower odds of developing any digestive disease (hazard ratio [HR], 0.72; 95% CI, 0.69-0.75) than those with a sleep score of 0/1.
• Of the 16 digestive diseases looked at, the reduction of risk was highest for irritable bowel syndrome at 50% (HR, 0.50; 95% CI, 0.45-0.57).
• A healthy sleep score was also associated with 37% reduced odds for metabolic dysfunction–associated steatotic liver disease (formerly known as nonalcoholic fatty liver disease; HR, 0.63; 95% CI, 0.55-0.71), 35% lower chance for peptic ulcer (HR, 0.65; 95% CI, 0.058-0.74), 34% reduced chance for dyspepsia (HR, 0.66; 95% CI, 0.58-0.75), and a 25% lower risk for diverticulosis (HR, 0.75; 95% CI, 0.71-0.80).
• High genetic risk and poor sleep scores were also associated with increased odds (53% to > 200%) of developing digestive diseases.
• However, healthy sleep reduced the risk for digestive diseases regardless of genetic susceptibility.

IN PRACTICE:

“Our findings underscore the potential holistic impact of different sleep behaviors in mitigating the risk of digestive diseases in clinical practice,” wrote Shiyi Yu, MD, of Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China, and colleagues.

Poor sleep can also change our gut microbiome, Dr. Yu told this news organization. If you don’t sleep well, the repair of the gut lining cannot be finished during the night.

SOURCE:

The study was presented at the Digestive Disease Week® (DDW), 2024, annual meeting.

DISCLOSURES:

Dr. Yu had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Ablation of the gastric fundus to reduce production of the “hunger hormone” ghrelin resulted in decreased appetite and significant weight loss among participants in a small first-in-human trial.

“Patients reported a decrease in hunger, appetite, and cravings and an increase in control over [their] eating,” said senior study investigator Christopher McGowan, MD, AGAF, a gastroenterologist in private practice and medical director of True You Weight Loss in Cary, North Carolina.

jaspugugatocokusamoslouoruchesahufraswuvithotocokaslicragisojuchuthibisovujigichotelistuswojut

Major Findings

In the trial, 10 women (mean age, 38 years; mean body mass index, 40.2) underwent endoscopic fundic mucosal ablation via hybrid argon plasma coagulation in an ambulatory setting under general anesthesia from November 1, 2022, to April 14, 2023. The procedure took less than an hour on average, and the technique gave them easy access to the fundus, Dr. McGowan said.

Compared with baseline, there were multiple beneficial outcomes at 6 months:

• 45% less circulating ghrelin in the blood.
• 53% drop in ghrelin-producing cells in the fundus.
• 42% reduction in stomach capacity.
• 43% decrease in hunger, appetite, and cravings.
• 7.7% body weight loss.

Over the 6 months of the study, mean ghrelin concentrations dropped from 461.6 pg/mL at baseline to 254.8 pg/mL (P = .006).

It is fascinating that the hormone ghrelin decreased just by ablating, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine and chair of DDW 2024. “They used the same device that we use to treat bleeding ulcers or lesions in the stomach and applied it broadly over the whole upper part of the stomach.”

cesputhabravesa

Another Anti-Obesity Tool?

“We’re all familiar with the epidemic that is obesity affecting nearly one in two adults, and the profound impact that it has on patients’ health, their quality of life, as well as the healthcare system,” Dr. McGowan said. “It’s clear that we need every tool possible to address this because we know that obesity is not a matter of willpower. It’s a disease.”

Gastric fundus ablation “may represent, and frankly should represent, a treatment option for the greater than 100 million US adults with obesity,” he added.

Not every patient wants to or can access GLP-1 medications, Dr. McGowan said. Also, “there’s a difference between taking a medication long-term, requiring an injection every week, vs a single intervention in time that carries forward.”

Ablation could also help people transition after they stop GLP-1 medications to help them maintain their weight loss, he said.

Weight loss is the endpoint you care about the most, said Dr. Laine, who co-moderated the press briefing.

Though the weight loss of 7.7% was not a large percentage, it was only 10 patients. We will have to see whether the total body weight loss is different when they do the procedure in more patients or if they can combine different mechanisms, Dr. Laine said.

It remains unclear whether gastric fundus ablation would be a stand-alone procedure or used in combination with another endoscopic weight-management intervention, bariatric surgery, or medication.

The endoscopic sleeve, which is a stomach-reducing procedure, is very effective, but it doesn’t diminish hunger, Dr. McGowan said. Combining it with ablation may be “a best-of-both-worlds scenario.”

Dr. Laine added that another open question is whether the gastric fundal accommodation will be associated with any side effects such as dyspepsia.

Dr. McGowan reported consulting for Boston Scientific and Apollo Endosurgery. Dr. Laine reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON — Ablation of the gastric fundus to reduce production of the “hunger hormone” ghrelin resulted in decreased appetite and significant weight loss among participants in a small first-in-human trial.

“Patients reported a decrease in hunger, appetite, and cravings and an increase in control over [their] eating,” said senior study investigator Christopher McGowan, MD, AGAF, a gastroenterologist in private practice and medical director of True You Weight Loss in Cary, North Carolina.

jaspugugatocokusamoslouoruchesahufraswuvithotocokaslicragisojuchuthibisovujigichotelistuswojut

Major Findings

In the trial, 10 women (mean age, 38 years; mean body mass index, 40.2) underwent endoscopic fundic mucosal ablation via hybrid argon plasma coagulation in an ambulatory setting under general anesthesia from November 1, 2022, to April 14, 2023. The procedure took less than an hour on average, and the technique gave them easy access to the fundus, Dr. McGowan said.

Compared with baseline, there were multiple beneficial outcomes at 6 months:

• 45% less circulating ghrelin in the blood.
• 53% drop in ghrelin-producing cells in the fundus.
• 42% reduction in stomach capacity.
• 43% decrease in hunger, appetite, and cravings.
• 7.7% body weight loss.

Over the 6 months of the study, mean ghrelin concentrations dropped from 461.6 pg/mL at baseline to 254.8 pg/mL (P = .006).

It is fascinating that the hormone ghrelin decreased just by ablating, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine and chair of DDW 2024. “They used the same device that we use to treat bleeding ulcers or lesions in the stomach and applied it broadly over the whole upper part of the stomach.”

cesputhabravesa

Another Anti-Obesity Tool?

“We’re all familiar with the epidemic that is obesity affecting nearly one in two adults, and the profound impact that it has on patients’ health, their quality of life, as well as the healthcare system,” Dr. McGowan said. “It’s clear that we need every tool possible to address this because we know that obesity is not a matter of willpower. It’s a disease.”

Gastric fundus ablation “may represent, and frankly should represent, a treatment option for the greater than 100 million US adults with obesity,” he added.

Not every patient wants to or can access GLP-1 medications, Dr. McGowan said. Also, “there’s a difference between taking a medication long-term, requiring an injection every week, vs a single intervention in time that carries forward.”

Ablation could also help people transition after they stop GLP-1 medications to help them maintain their weight loss, he said.

Weight loss is the endpoint you care about the most, said Dr. Laine, who co-moderated the press briefing.

Though the weight loss of 7.7% was not a large percentage, it was only 10 patients. We will have to see whether the total body weight loss is different when they do the procedure in more patients or if they can combine different mechanisms, Dr. Laine said.

It remains unclear whether gastric fundus ablation would be a stand-alone procedure or used in combination with another endoscopic weight-management intervention, bariatric surgery, or medication.

The endoscopic sleeve, which is a stomach-reducing procedure, is very effective, but it doesn’t diminish hunger, Dr. McGowan said. Combining it with ablation may be “a best-of-both-worlds scenario.”

Dr. Laine added that another open question is whether the gastric fundal accommodation will be associated with any side effects such as dyspepsia.

Dr. McGowan reported consulting for Boston Scientific and Apollo Endosurgery. Dr. Laine reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON — Ablation of the gastric fundus to reduce production of the “hunger hormone” ghrelin resulted in decreased appetite and significant weight loss among participants in a small first-in-human trial.

“Patients reported a decrease in hunger, appetite, and cravings and an increase in control over [their] eating,” said senior study investigator Christopher McGowan, MD, AGAF, a gastroenterologist in private practice and medical director of True You Weight Loss in Cary, North Carolina.

jaspugugatocokusamoslouoruchesahufraswuvithotocokaslicragisojuchuthibisovujigichotelistuswojut

Major Findings

In the trial, 10 women (mean age, 38 years; mean body mass index, 40.2) underwent endoscopic fundic mucosal ablation via hybrid argon plasma coagulation in an ambulatory setting under general anesthesia from November 1, 2022, to April 14, 2023. The procedure took less than an hour on average, and the technique gave them easy access to the fundus, Dr. McGowan said.

Compared with baseline, there were multiple beneficial outcomes at 6 months:

• 45% less circulating ghrelin in the blood.
• 53% drop in ghrelin-producing cells in the fundus.
• 42% reduction in stomach capacity.
• 43% decrease in hunger, appetite, and cravings.
• 7.7% body weight loss.

Over the 6 months of the study, mean ghrelin concentrations dropped from 461.6 pg/mL at baseline to 254.8 pg/mL (P = .006).

It is fascinating that the hormone ghrelin decreased just by ablating, said Loren Laine, MD, AGAF, professor of medicine (digestive diseases) at Yale School of Medicine and chair of DDW 2024. “They used the same device that we use to treat bleeding ulcers or lesions in the stomach and applied it broadly over the whole upper part of the stomach.”

cesputhabravesa

Another Anti-Obesity Tool?

“We’re all familiar with the epidemic that is obesity affecting nearly one in two adults, and the profound impact that it has on patients’ health, their quality of life, as well as the healthcare system,” Dr. McGowan said. “It’s clear that we need every tool possible to address this because we know that obesity is not a matter of willpower. It’s a disease.”

Gastric fundus ablation “may represent, and frankly should represent, a treatment option for the greater than 100 million US adults with obesity,” he added.

Not every patient wants to or can access GLP-1 medications, Dr. McGowan said. Also, “there’s a difference between taking a medication long-term, requiring an injection every week, vs a single intervention in time that carries forward.”

Ablation could also help people transition after they stop GLP-1 medications to help them maintain their weight loss, he said.

Weight loss is the endpoint you care about the most, said Dr. Laine, who co-moderated the press briefing.

Though the weight loss of 7.7% was not a large percentage, it was only 10 patients. We will have to see whether the total body weight loss is different when they do the procedure in more patients or if they can combine different mechanisms, Dr. Laine said.

It remains unclear whether gastric fundus ablation would be a stand-alone procedure or used in combination with another endoscopic weight-management intervention, bariatric surgery, or medication.

The endoscopic sleeve, which is a stomach-reducing procedure, is very effective, but it doesn’t diminish hunger, Dr. McGowan said. Combining it with ablation may be “a best-of-both-worlds scenario.”

Dr. Laine added that another open question is whether the gastric fundal accommodation will be associated with any side effects such as dyspepsia.

Dr. McGowan reported consulting for Boston Scientific and Apollo Endosurgery. Dr. Laine reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Introduction

Barrett’s esophagus (BE) is characterized by the replacement of squamous epithelium by columnar metaplasia of the distal esophagus (>1 cm length). It is a precancerous condition, with 3%-5% of patients with BE developing esophageal adenocarcinoma (EAC) in their lifetime. EAC is one of the cancers with high morbidity and mortality (5-year survival < 20%), and its incidence has been on the rise. Studies examining the natural history of BE have demonstrated that the progression happens through a metaplasia-dysplasia-neoplasia sequence. Therefore, early detection of BE and timely management to prevent progression to EAC is crucial.

Grades of Dysplasia

The current gold standard for the diagnosis of BE neoplasia includes a high-quality endoscopic evaluation and biopsies. Biopsies should be obtained from any visible lesions (nodules, ulcers) followed by a random 4-quadrant fashion (Seattle protocol) interval of the entire length of the BE segment. It is essential to pay attention to the results of the biopsy that have been obtained since it will not only determine the surveillance interval but is crucial in planning any necessary endoscopic therapy. The possible results of the biopsy and its implications are:

• No intestinal metaplasia (IM): This would rule out Barrett’s esophagus and no further surveillance would be necessary. A recent population-based study of over 1 million patients showed a 55% and 61% reduced risk of upper gastrointestinal (UGI) cancer and deaths respectively after a negative endoscopy.¹
• Intestinal metaplasia with no dysplasia (non-dysplastic BE): Biopsies confirm presence of intestinal metaplasia in the biopsies without any evidence of dysplasia. While the rate of progression to EAC is low (0.07%-0.25%), it is not absent and thus surveillance would be indicated. Current guidelines suggest repeating an endoscopy with biopsy in 5 years if the length of BE is < 3 cm or 3 years if length of BE ≥ 3 cm.²
• Indeterminate for dysplasia (BE-IND): Biopsies confirm IM but are not able to definitively rule out dysplasia. This can be seen in about 4%-8% of the biopsies obtained. The progression rates to EAC are reported to be comparable or lower to low-grade dysplasia (LGD), so the current recommendation is to intensify acid reduction therapy and repeat endoscopy in 6 months. If repeat endoscopy downgrades to non-dysplastic, then can follow surveillance according to NDBE protocol; otherwise recommend continuing surveillance every 12 months.
• Low-grade dysplasia (BE-LGD): Biopsies confirm IM but also show tightly packed overlapping basal nuclei with hyperchromasia and irregular contours, basal stratification of nuclei, and diminished goblet and columnar cell mucus. There is significant inter-observer variability reported,³ and thus the slides must be reviewed by a second pathologist with experience in BE to confirm the findings. Once confirmed, based on risk factors such as presence of multifocal LGD, persistence of LGD, presence of visible lesions, etc., the patient can be offered Barrett’s endoscopic therapy (BET) or undergo continued surveillance. The decision of pursuing one or the other would be dependent on patient preference and shared decision-making between the patient and the provider.
• High-grade dysplasia (BE-HGD): Biopsies confirm IM with cells showing greater degree of cytologic and architectural alterations of dysplasia than LGD but without overt neoplastic features. Over 40% of the patients would progress to EAC and thus the current recommendations would be to recommend BET in these patients.⁴
• Esophageal adenocarcinoma (EAC): Biopsies demonstrate neoplasia. If the neoplastic changes are limited to the mucosa (T1a) on endoscopic ultrasound or cross-sectional imaging, then BET is suggested. If there is involvement of submucosa, then depending on the depth of invasion, absence of high-risk features (poor differentiation, lymphovascular invasion), BET can be considered as an alternative to esophagectomy.

Lesion Detection on Endoscopy

Data from large population-based studies with at least 3 years of follow-up reported that 58%-66% of EAC detected during endoscopy were diagnosed within 1 year of an index Barrett’s esophagus screening endoscopy, or post-endoscopy Barrett’s neoplasia, and were considered likely to have been missed during index endoscopy.⁵ This underscores the importance of careful and systematic endoscopic examination during an upper endoscopy.

Studies have also demonstrated that longer examination time was associated with significantly higher detection of HGD/EAC.^6,7 Careful examination of the tubular esophagus and gastroesophageal junction (GEJ) should be performed in forward and retroflexed views looking for any subtle areas of nodularity, loop distortion, variability in vascular patterns, mucosal changes concerning for dysplasia or neoplasia. Use of high-definition white light endoscopy (HD-WLE) and virtual chromoendoscopy techniques such as narrow banding imaging (NBI) or blue laser imaging (BLI) are currently recommended in the guidelines.² Spray chromoendoscopy using acetic acid can also be utilized. Another exciting development is the use of artificial intelligence (AI) in detecting and diagnosing BE associated lesions and neoplasia.
 

Barrett’s Endoscopic Therapy (BET)

Patients with visible lesions, dysplasia, or early EAC are candidates for BET (Table 1).

167527_table_web.jpg

BET involves resective and ablative modalities. The resective modalities include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) and are the modalities of choice for nodular or raised lesions.

EMR involves endoscopic resection of abnormal mucosa using either lift-assisted technique or multi-band ligation (Figure 1).

167527_figure_web.jpg

ESD, on the other hand, involves submucosal dissection and perimeter resection of the lesion, thus providing the advantage of an en-bloc resection. In a recent randomized controlled trial (RCT) of 40 patients undergoing ESD vs EMR for HGD/EAC, ESD was better for curative resection (R0) (58%) compared with EMR (12%); however, the remission rates at 3 months were comparable with two perforations reported in the ESD group while there were no complications in the EMR group.⁸

There is an apparent learning curve when it comes to these advanced techniques, and with more experience, we are seeing comparable results for both these modalities. However, given the complexity and time required for the procedure, current practices typically involve preserving ESD for lesions > 2 cm, those having a likelihood of cancer in the superficial submucosa, or those that EMR cannot remove due to underlying fibrosis or post-EMR recurrence.

Srinivasan_Sachin_KS_web.jpg

Barrett’s Refractory to Endoscopic Therapy

Failure of BET is defined as persistent columnar lined epithelium (intestinal metaplasia) with inadequate response, after adequate attempts at endoscopic ablation therapy (after resection) with at least four ablation sessions.¹³ If encountered, special attention must be given to check compliance with proton pump inhibitors (PPIs), previous incomplete resection, and presence of large hiatal hernia. If CE-IM is not achieved after multiple sessions, change of ablative modality is typically considered. In addition, careful examination for visible lesions should be performed and even if a small one is noted, this should be first resected prior to application of any ablative therapy.

Sharma_Prateek_KS_2024_web.jpg

Currently there are no guideline recommendations regarding the preference of one endoscopic modality over another or consideration of potential endoscopic or surgical fundoplication. These modalities primarily rely on technologies available at an institution and the preference of a provider based on their training and experience. Most studies indicate 1-3 sessions (~ 3 months apart) of ablative treatment before achieving CE-IM.
 

Success and Adverse Events of BET

In a recent real-world study of over 27,000 patients with dysplastic BE, 5295 underwent BET. Analysis showed that patients with HGD/EAC who had BET had a significantly lower 3-year mortality (HGD: RR, 0.59; 95%CI, 0.49-0.71; EAC: RR, 0.53; 95% CI, 0.44-0.65) compared with those who did not undergo BET. Esophageal strictures were the most common adverse event and were noted in 6.5%, followed by chest pain (1.8%), upper GI bleeding (0.47%), and esophageal perforation (0.2%).¹⁴

In general, adverse events can be divided into immediate and delayed adverse events. Immediate adverse events typically involve bleeding and perforation that can occur during or shortly after the procedure. These are reported at higher rates with resective modalities compared with ablative therapies. Standard endoscopic techniques involving coagulation grasper or clips can be used to achieve hemostasis. Endoscopic suturing devices offer the ability to contain any perforation. The need for surgical intervention is small and limited to adverse events not detected during the procedure.

Delayed adverse events such as stricture and stenosis are higher for resective modalities (up to 30%), especially when involving more significant than 75% of the esophageal circumference. Post-procedural pain/dysphagia is most common after ablative therapies. Dysphagia reported after any endoscopic therapy should be promptly evaluated, and sequential dilation until the goal esophageal lumen is achieved should be performed every 2-4 weeks.
 

Recurrences and Surveillance After BET

What is established is that recurrences can occur and may be subtle, therefore detailed endoscopic surveillance is required. In a prospective study, recurrence rates of 15%-16% for IM and 3%-5% for any dysplasia were reported, with the majority being in the first 2 years after achieving CE-IM.¹⁵ A systematic review of 21 studies looking at the location of recurrences suggested that the majority (56%) occur in the distal esophagus. Of those that occur in the esophagus, about 80% of them were in the distal 2 cm of the esophagus and only 50% of the recurrences were visible recurrences, thus reiterating the importance of meticulous examination and systematic biopsies.¹⁶

On the contrary, a recent single-center study of 217 patients who had achieved CE-IM with 5.5 years of follow-up demonstrated a 26% and 8% recurrence of IM and dysplasia, respectively. One hundred percent of the recurrence in the esophagus was reported as visible.¹⁷ Therefore, follow-up endoscopy surveillance protocol after CE-IM should still involve meticulous examination, biopsy of visible lesions, and systematic biopsies for non-visible lesions from the original BE segment, similar to those patients who have not needed BET.

Current guidelines based on expert consensus and evidence recommend surveillance after CE-IM based on original most advanced histology:²

1. LGD: 1 year, 3 years, and every 2 years after that.

2. HGD/EAC: 3 months, 6 months, 12 months, and annually after that.

There is no clear guideline on when to stop surveillance since the longest available follow-up is around 10 years, and recurrences are still detected. A potential surveillance endpoint may be based on age and comorbidities, especially those that would preclude a patient from being a candidate for BET.
 

When Should a Patient Be Referred?

BE patients with visible lesions and/or dysplastic changes in the biopsy who would require BET should be considered for referral to high-volume centers. Studies have shown higher success for CE-IM and lower rates of adverse events and recurrences in these patients managed at expert centers. The presence of a multidisciplinary team involving pathologists, surgeons, and oncologists is critical and offers a timely opportunity in case of need for a high-risk patient.

Conclusion

BE is a precursor to EAC, with rising incidence and poor 5-year survival. Endoscopic diagnosis is the gold standard and requires a high-quality examination and biopsies. Based on histopathology, a systematic surveillance and BET plan should be performed to achieve CE-IM in patients with dysplasia. Once CE-IM is achieved, regular surveillance should be performed with careful attention to recurrences and complications from the BET modalities.

Dr. Srinivasan and Dr. Sharma are based at the University of Kansas Medical Center, Kansas City, Kansas, and the Kansas City Veterans Affairs Medical Center, Kansas City, Missouri. Dr. Srinivasan has no relevant disclosures. Dr. Sharma disclosed research grants from ERBE, Ironwood Pharmaceuticals, Olympus, and Medtronic. He has served as a consultant for Takeda, Samsung Bioepis, Olympus, and Lumendi, and reports other funding from Medtronic, Fujifilm Medical Systems USA, and Salix.

References

1. Holmberg D, et al. Incidence and mortality in upper gastrointestinal cancer after negative endoscopy for gastroesophageal reflux disease. Gastroenterology. 2022;162(2):431-438.e4.

2. Shaheen NJ, et al. Diagnosis and management of Barrett’s esophagus: An updated ACG guideline. Am J Gastroenterol. 2022 Apr;117(4):559-587.

3. Pech O, et al. Inter-observer variability in the diagnosis of low-grade dysplasia in pathologists: A comparison between experienced and inexperienced pathologists. Gastrointest Endosc. 2006 Apr;63(5):AB130.

4. Krishnamoorthi R, et al. Factors associated with progression of Barrett’s esophagus: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1046-1055.e8.

5. Visrodia K, et al. Magnitude of missed esophageal adenocarcinoma after Barrett’s esophagus diagnosis: A systematic review and meta-analysis. Gastroenterology. 2016 Mar;150(3):599-607.e7; quiz e14-5.

6. Perisetti A, Sharma P. Tips for improving the identification of neoplastic visible lesions in Barrett’s esophagus. Gastrointest Endosc. 2023 Feb;97(2):248-250.

7. Gupta N, et al. Longer inspection time is associated with increased detection of high-grade dysplasia and esophageal adenocarcinoma in Barrett’s esophagus. Gastrointest Endosc. 2012 Sep;76(3):531-538.

8. Terheggen G, et al. A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett’s neoplasia. Gut. 2017 May;66(5):783-793.

9. Wolfson P, et al. Endoscopic eradication therapy for Barrett’s esophagus-related neoplasia: A final 10-year report from the UK National HALO Radiofrequency Ablation Registry. Gastrointest Endosc. 2022 Aug;96(2):223-233.

10. Rösch T, et al. 1151 Multicenter feasibility study of combined injection and argon plasma coagulation (hybrid-APC) in the ablation therapy of neoplastic Barrett esophagus. Gastrointest Endosc. 2017;85(5):AB154.

11. Knabe M, et al. Radiofrequency ablation versus hybrid argon plasma coagulation in Barrett’s esophagus: A prospective randomised trial. Surg Endosc. 2023;37(10):7803-7811.

12. Van Munster SN, et al. Radiofrequency vapor ablation for Barrett’s esophagus: Feasibility, safety, and proof of concept in a stepwise study with in vitro, animal, and the first in-human application. Endoscopy. 2021 Nov;53(11):1162-1168.

13. Emura F, et al. Rio de Janeiro global consensus on landmarks, definitions, and classifications in Barrett’s esophagus: World Endoscopy Organization Delphi study. Gastroenterology. 2022 Jul;163(1):84-96.e2.

14. Singh RR, et al. Real-world evidence of safety and effectiveness of Barrett’s endoscopic therapy. Gastrointest Endosc. 2023 Aug;98(2):155-161.e1.

15. Wani S, et al. Recurrence Is rare following complete eradication of intestinal metaplasia in patients with Barrett’s esophagus and peaks at 18 months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2.

16. Duvvuri A, et al. Mo1273 Location and pattern of recurrences in patients with Barrett’s esophagus after endoscopic therapy: A systematic review and critical analysis of the published literature. Gastrointest Endosc. 2020;91(6):AB410-1.

17. He T, et al. Location and appearance of dysplastic Barrett’s esophagus recurrence after endoscopic eradication therapy: No additional yield from random biopsy sampling neosquamous mucosa. Gastrointest Endosc. 2023 Nov;98(5):722-732.

Introduction

Barrett’s esophagus (BE) is characterized by the replacement of squamous epithelium by columnar metaplasia of the distal esophagus (>1 cm length). It is a precancerous condition, with 3%-5% of patients with BE developing esophageal adenocarcinoma (EAC) in their lifetime. EAC is one of the cancers with high morbidity and mortality (5-year survival < 20%), and its incidence has been on the rise. Studies examining the natural history of BE have demonstrated that the progression happens through a metaplasia-dysplasia-neoplasia sequence. Therefore, early detection of BE and timely management to prevent progression to EAC is crucial.

Grades of Dysplasia

The current gold standard for the diagnosis of BE neoplasia includes a high-quality endoscopic evaluation and biopsies. Biopsies should be obtained from any visible lesions (nodules, ulcers) followed by a random 4-quadrant fashion (Seattle protocol) interval of the entire length of the BE segment. It is essential to pay attention to the results of the biopsy that have been obtained since it will not only determine the surveillance interval but is crucial in planning any necessary endoscopic therapy. The possible results of the biopsy and its implications are:

• No intestinal metaplasia (IM): This would rule out Barrett’s esophagus and no further surveillance would be necessary. A recent population-based study of over 1 million patients showed a 55% and 61% reduced risk of upper gastrointestinal (UGI) cancer and deaths respectively after a negative endoscopy.¹
• Intestinal metaplasia with no dysplasia (non-dysplastic BE): Biopsies confirm presence of intestinal metaplasia in the biopsies without any evidence of dysplasia. While the rate of progression to EAC is low (0.07%-0.25%), it is not absent and thus surveillance would be indicated. Current guidelines suggest repeating an endoscopy with biopsy in 5 years if the length of BE is < 3 cm or 3 years if length of BE ≥ 3 cm.²
• Indeterminate for dysplasia (BE-IND): Biopsies confirm IM but are not able to definitively rule out dysplasia. This can be seen in about 4%-8% of the biopsies obtained. The progression rates to EAC are reported to be comparable or lower to low-grade dysplasia (LGD), so the current recommendation is to intensify acid reduction therapy and repeat endoscopy in 6 months. If repeat endoscopy downgrades to non-dysplastic, then can follow surveillance according to NDBE protocol; otherwise recommend continuing surveillance every 12 months.
• Low-grade dysplasia (BE-LGD): Biopsies confirm IM but also show tightly packed overlapping basal nuclei with hyperchromasia and irregular contours, basal stratification of nuclei, and diminished goblet and columnar cell mucus. There is significant inter-observer variability reported,³ and thus the slides must be reviewed by a second pathologist with experience in BE to confirm the findings. Once confirmed, based on risk factors such as presence of multifocal LGD, persistence of LGD, presence of visible lesions, etc., the patient can be offered Barrett’s endoscopic therapy (BET) or undergo continued surveillance. The decision of pursuing one or the other would be dependent on patient preference and shared decision-making between the patient and the provider.
• High-grade dysplasia (BE-HGD): Biopsies confirm IM with cells showing greater degree of cytologic and architectural alterations of dysplasia than LGD but without overt neoplastic features. Over 40% of the patients would progress to EAC and thus the current recommendations would be to recommend BET in these patients.⁴
• Esophageal adenocarcinoma (EAC): Biopsies demonstrate neoplasia. If the neoplastic changes are limited to the mucosa (T1a) on endoscopic ultrasound or cross-sectional imaging, then BET is suggested. If there is involvement of submucosa, then depending on the depth of invasion, absence of high-risk features (poor differentiation, lymphovascular invasion), BET can be considered as an alternative to esophagectomy.

Lesion Detection on Endoscopy

Data from large population-based studies with at least 3 years of follow-up reported that 58%-66% of EAC detected during endoscopy were diagnosed within 1 year of an index Barrett’s esophagus screening endoscopy, or post-endoscopy Barrett’s neoplasia, and were considered likely to have been missed during index endoscopy.⁵ This underscores the importance of careful and systematic endoscopic examination during an upper endoscopy.

Studies have also demonstrated that longer examination time was associated with significantly higher detection of HGD/EAC.^6,7 Careful examination of the tubular esophagus and gastroesophageal junction (GEJ) should be performed in forward and retroflexed views looking for any subtle areas of nodularity, loop distortion, variability in vascular patterns, mucosal changes concerning for dysplasia or neoplasia. Use of high-definition white light endoscopy (HD-WLE) and virtual chromoendoscopy techniques such as narrow banding imaging (NBI) or blue laser imaging (BLI) are currently recommended in the guidelines.² Spray chromoendoscopy using acetic acid can also be utilized. Another exciting development is the use of artificial intelligence (AI) in detecting and diagnosing BE associated lesions and neoplasia.
 

Barrett’s Endoscopic Therapy (BET)

Patients with visible lesions, dysplasia, or early EAC are candidates for BET (Table 1).

167527_table_web.jpg

BET involves resective and ablative modalities. The resective modalities include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) and are the modalities of choice for nodular or raised lesions.

EMR involves endoscopic resection of abnormal mucosa using either lift-assisted technique or multi-band ligation (Figure 1).

167527_figure_web.jpg

ESD, on the other hand, involves submucosal dissection and perimeter resection of the lesion, thus providing the advantage of an en-bloc resection. In a recent randomized controlled trial (RCT) of 40 patients undergoing ESD vs EMR for HGD/EAC, ESD was better for curative resection (R0) (58%) compared with EMR (12%); however, the remission rates at 3 months were comparable with two perforations reported in the ESD group while there were no complications in the EMR group.⁸

There is an apparent learning curve when it comes to these advanced techniques, and with more experience, we are seeing comparable results for both these modalities. However, given the complexity and time required for the procedure, current practices typically involve preserving ESD for lesions > 2 cm, those having a likelihood of cancer in the superficial submucosa, or those that EMR cannot remove due to underlying fibrosis or post-EMR recurrence.

Srinivasan_Sachin_KS_web.jpg

Barrett’s Refractory to Endoscopic Therapy

Failure of BET is defined as persistent columnar lined epithelium (intestinal metaplasia) with inadequate response, after adequate attempts at endoscopic ablation therapy (after resection) with at least four ablation sessions.¹³ If encountered, special attention must be given to check compliance with proton pump inhibitors (PPIs), previous incomplete resection, and presence of large hiatal hernia. If CE-IM is not achieved after multiple sessions, change of ablative modality is typically considered. In addition, careful examination for visible lesions should be performed and even if a small one is noted, this should be first resected prior to application of any ablative therapy.

Sharma_Prateek_KS_2024_web.jpg

Currently there are no guideline recommendations regarding the preference of one endoscopic modality over another or consideration of potential endoscopic or surgical fundoplication. These modalities primarily rely on technologies available at an institution and the preference of a provider based on their training and experience. Most studies indicate 1-3 sessions (~ 3 months apart) of ablative treatment before achieving CE-IM.
 

Success and Adverse Events of BET

In a recent real-world study of over 27,000 patients with dysplastic BE, 5295 underwent BET. Analysis showed that patients with HGD/EAC who had BET had a significantly lower 3-year mortality (HGD: RR, 0.59; 95%CI, 0.49-0.71; EAC: RR, 0.53; 95% CI, 0.44-0.65) compared with those who did not undergo BET. Esophageal strictures were the most common adverse event and were noted in 6.5%, followed by chest pain (1.8%), upper GI bleeding (0.47%), and esophageal perforation (0.2%).¹⁴

In general, adverse events can be divided into immediate and delayed adverse events. Immediate adverse events typically involve bleeding and perforation that can occur during or shortly after the procedure. These are reported at higher rates with resective modalities compared with ablative therapies. Standard endoscopic techniques involving coagulation grasper or clips can be used to achieve hemostasis. Endoscopic suturing devices offer the ability to contain any perforation. The need for surgical intervention is small and limited to adverse events not detected during the procedure.

Delayed adverse events such as stricture and stenosis are higher for resective modalities (up to 30%), especially when involving more significant than 75% of the esophageal circumference. Post-procedural pain/dysphagia is most common after ablative therapies. Dysphagia reported after any endoscopic therapy should be promptly evaluated, and sequential dilation until the goal esophageal lumen is achieved should be performed every 2-4 weeks.
 

Recurrences and Surveillance After BET

What is established is that recurrences can occur and may be subtle, therefore detailed endoscopic surveillance is required. In a prospective study, recurrence rates of 15%-16% for IM and 3%-5% for any dysplasia were reported, with the majority being in the first 2 years after achieving CE-IM.¹⁵ A systematic review of 21 studies looking at the location of recurrences suggested that the majority (56%) occur in the distal esophagus. Of those that occur in the esophagus, about 80% of them were in the distal 2 cm of the esophagus and only 50% of the recurrences were visible recurrences, thus reiterating the importance of meticulous examination and systematic biopsies.¹⁶

On the contrary, a recent single-center study of 217 patients who had achieved CE-IM with 5.5 years of follow-up demonstrated a 26% and 8% recurrence of IM and dysplasia, respectively. One hundred percent of the recurrence in the esophagus was reported as visible.¹⁷ Therefore, follow-up endoscopy surveillance protocol after CE-IM should still involve meticulous examination, biopsy of visible lesions, and systematic biopsies for non-visible lesions from the original BE segment, similar to those patients who have not needed BET.

Current guidelines based on expert consensus and evidence recommend surveillance after CE-IM based on original most advanced histology:²

1. LGD: 1 year, 3 years, and every 2 years after that.

2. HGD/EAC: 3 months, 6 months, 12 months, and annually after that.

There is no clear guideline on when to stop surveillance since the longest available follow-up is around 10 years, and recurrences are still detected. A potential surveillance endpoint may be based on age and comorbidities, especially those that would preclude a patient from being a candidate for BET.
 

When Should a Patient Be Referred?

BE patients with visible lesions and/or dysplastic changes in the biopsy who would require BET should be considered for referral to high-volume centers. Studies have shown higher success for CE-IM and lower rates of adverse events and recurrences in these patients managed at expert centers. The presence of a multidisciplinary team involving pathologists, surgeons, and oncologists is critical and offers a timely opportunity in case of need for a high-risk patient.

Conclusion

BE is a precursor to EAC, with rising incidence and poor 5-year survival. Endoscopic diagnosis is the gold standard and requires a high-quality examination and biopsies. Based on histopathology, a systematic surveillance and BET plan should be performed to achieve CE-IM in patients with dysplasia. Once CE-IM is achieved, regular surveillance should be performed with careful attention to recurrences and complications from the BET modalities.

Dr. Srinivasan and Dr. Sharma are based at the University of Kansas Medical Center, Kansas City, Kansas, and the Kansas City Veterans Affairs Medical Center, Kansas City, Missouri. Dr. Srinivasan has no relevant disclosures. Dr. Sharma disclosed research grants from ERBE, Ironwood Pharmaceuticals, Olympus, and Medtronic. He has served as a consultant for Takeda, Samsung Bioepis, Olympus, and Lumendi, and reports other funding from Medtronic, Fujifilm Medical Systems USA, and Salix.

References

1. Holmberg D, et al. Incidence and mortality in upper gastrointestinal cancer after negative endoscopy for gastroesophageal reflux disease. Gastroenterology. 2022;162(2):431-438.e4.

2. Shaheen NJ, et al. Diagnosis and management of Barrett’s esophagus: An updated ACG guideline. Am J Gastroenterol. 2022 Apr;117(4):559-587.

3. Pech O, et al. Inter-observer variability in the diagnosis of low-grade dysplasia in pathologists: A comparison between experienced and inexperienced pathologists. Gastrointest Endosc. 2006 Apr;63(5):AB130.

4. Krishnamoorthi R, et al. Factors associated with progression of Barrett’s esophagus: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1046-1055.e8.

5. Visrodia K, et al. Magnitude of missed esophageal adenocarcinoma after Barrett’s esophagus diagnosis: A systematic review and meta-analysis. Gastroenterology. 2016 Mar;150(3):599-607.e7; quiz e14-5.

6. Perisetti A, Sharma P. Tips for improving the identification of neoplastic visible lesions in Barrett’s esophagus. Gastrointest Endosc. 2023 Feb;97(2):248-250.

7. Gupta N, et al. Longer inspection time is associated with increased detection of high-grade dysplasia and esophageal adenocarcinoma in Barrett’s esophagus. Gastrointest Endosc. 2012 Sep;76(3):531-538.

8. Terheggen G, et al. A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett’s neoplasia. Gut. 2017 May;66(5):783-793.

9. Wolfson P, et al. Endoscopic eradication therapy for Barrett’s esophagus-related neoplasia: A final 10-year report from the UK National HALO Radiofrequency Ablation Registry. Gastrointest Endosc. 2022 Aug;96(2):223-233.

10. Rösch T, et al. 1151 Multicenter feasibility study of combined injection and argon plasma coagulation (hybrid-APC) in the ablation therapy of neoplastic Barrett esophagus. Gastrointest Endosc. 2017;85(5):AB154.

11. Knabe M, et al. Radiofrequency ablation versus hybrid argon plasma coagulation in Barrett’s esophagus: A prospective randomised trial. Surg Endosc. 2023;37(10):7803-7811.

12. Van Munster SN, et al. Radiofrequency vapor ablation for Barrett’s esophagus: Feasibility, safety, and proof of concept in a stepwise study with in vitro, animal, and the first in-human application. Endoscopy. 2021 Nov;53(11):1162-1168.

13. Emura F, et al. Rio de Janeiro global consensus on landmarks, definitions, and classifications in Barrett’s esophagus: World Endoscopy Organization Delphi study. Gastroenterology. 2022 Jul;163(1):84-96.e2.

14. Singh RR, et al. Real-world evidence of safety and effectiveness of Barrett’s endoscopic therapy. Gastrointest Endosc. 2023 Aug;98(2):155-161.e1.

15. Wani S, et al. Recurrence Is rare following complete eradication of intestinal metaplasia in patients with Barrett’s esophagus and peaks at 18 months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2.

16. Duvvuri A, et al. Mo1273 Location and pattern of recurrences in patients with Barrett’s esophagus after endoscopic therapy: A systematic review and critical analysis of the published literature. Gastrointest Endosc. 2020;91(6):AB410-1.

17. He T, et al. Location and appearance of dysplastic Barrett’s esophagus recurrence after endoscopic eradication therapy: No additional yield from random biopsy sampling neosquamous mucosa. Gastrointest Endosc. 2023 Nov;98(5):722-732.

Introduction

Barrett’s esophagus (BE) is characterized by the replacement of squamous epithelium by columnar metaplasia of the distal esophagus (>1 cm length). It is a precancerous condition, with 3%-5% of patients with BE developing esophageal adenocarcinoma (EAC) in their lifetime. EAC is one of the cancers with high morbidity and mortality (5-year survival < 20%), and its incidence has been on the rise. Studies examining the natural history of BE have demonstrated that the progression happens through a metaplasia-dysplasia-neoplasia sequence. Therefore, early detection of BE and timely management to prevent progression to EAC is crucial.

Grades of Dysplasia

The current gold standard for the diagnosis of BE neoplasia includes a high-quality endoscopic evaluation and biopsies. Biopsies should be obtained from any visible lesions (nodules, ulcers) followed by a random 4-quadrant fashion (Seattle protocol) interval of the entire length of the BE segment. It is essential to pay attention to the results of the biopsy that have been obtained since it will not only determine the surveillance interval but is crucial in planning any necessary endoscopic therapy. The possible results of the biopsy and its implications are:

• No intestinal metaplasia (IM): This would rule out Barrett’s esophagus and no further surveillance would be necessary. A recent population-based study of over 1 million patients showed a 55% and 61% reduced risk of upper gastrointestinal (UGI) cancer and deaths respectively after a negative endoscopy.¹
• Intestinal metaplasia with no dysplasia (non-dysplastic BE): Biopsies confirm presence of intestinal metaplasia in the biopsies without any evidence of dysplasia. While the rate of progression to EAC is low (0.07%-0.25%), it is not absent and thus surveillance would be indicated. Current guidelines suggest repeating an endoscopy with biopsy in 5 years if the length of BE is < 3 cm or 3 years if length of BE ≥ 3 cm.²
• Indeterminate for dysplasia (BE-IND): Biopsies confirm IM but are not able to definitively rule out dysplasia. This can be seen in about 4%-8% of the biopsies obtained. The progression rates to EAC are reported to be comparable or lower to low-grade dysplasia (LGD), so the current recommendation is to intensify acid reduction therapy and repeat endoscopy in 6 months. If repeat endoscopy downgrades to non-dysplastic, then can follow surveillance according to NDBE protocol; otherwise recommend continuing surveillance every 12 months.
• Low-grade dysplasia (BE-LGD): Biopsies confirm IM but also show tightly packed overlapping basal nuclei with hyperchromasia and irregular contours, basal stratification of nuclei, and diminished goblet and columnar cell mucus. There is significant inter-observer variability reported,³ and thus the slides must be reviewed by a second pathologist with experience in BE to confirm the findings. Once confirmed, based on risk factors such as presence of multifocal LGD, persistence of LGD, presence of visible lesions, etc., the patient can be offered Barrett’s endoscopic therapy (BET) or undergo continued surveillance. The decision of pursuing one or the other would be dependent on patient preference and shared decision-making between the patient and the provider.
• High-grade dysplasia (BE-HGD): Biopsies confirm IM with cells showing greater degree of cytologic and architectural alterations of dysplasia than LGD but without overt neoplastic features. Over 40% of the patients would progress to EAC and thus the current recommendations would be to recommend BET in these patients.⁴
• Esophageal adenocarcinoma (EAC): Biopsies demonstrate neoplasia. If the neoplastic changes are limited to the mucosa (T1a) on endoscopic ultrasound or cross-sectional imaging, then BET is suggested. If there is involvement of submucosa, then depending on the depth of invasion, absence of high-risk features (poor differentiation, lymphovascular invasion), BET can be considered as an alternative to esophagectomy.

Lesion Detection on Endoscopy

Data from large population-based studies with at least 3 years of follow-up reported that 58%-66% of EAC detected during endoscopy were diagnosed within 1 year of an index Barrett’s esophagus screening endoscopy, or post-endoscopy Barrett’s neoplasia, and were considered likely to have been missed during index endoscopy.⁵ This underscores the importance of careful and systematic endoscopic examination during an upper endoscopy.

Studies have also demonstrated that longer examination time was associated with significantly higher detection of HGD/EAC.^6,7 Careful examination of the tubular esophagus and gastroesophageal junction (GEJ) should be performed in forward and retroflexed views looking for any subtle areas of nodularity, loop distortion, variability in vascular patterns, mucosal changes concerning for dysplasia or neoplasia. Use of high-definition white light endoscopy (HD-WLE) and virtual chromoendoscopy techniques such as narrow banding imaging (NBI) or blue laser imaging (BLI) are currently recommended in the guidelines.² Spray chromoendoscopy using acetic acid can also be utilized. Another exciting development is the use of artificial intelligence (AI) in detecting and diagnosing BE associated lesions and neoplasia.
 

Barrett’s Endoscopic Therapy (BET)

Patients with visible lesions, dysplasia, or early EAC are candidates for BET (Table 1).

167527_table_web.jpg

BET involves resective and ablative modalities. The resective modalities include endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) and are the modalities of choice for nodular or raised lesions.

EMR involves endoscopic resection of abnormal mucosa using either lift-assisted technique or multi-band ligation (Figure 1).

167527_figure_web.jpg

ESD, on the other hand, involves submucosal dissection and perimeter resection of the lesion, thus providing the advantage of an en-bloc resection. In a recent randomized controlled trial (RCT) of 40 patients undergoing ESD vs EMR for HGD/EAC, ESD was better for curative resection (R0) (58%) compared with EMR (12%); however, the remission rates at 3 months were comparable with two perforations reported in the ESD group while there were no complications in the EMR group.⁸

There is an apparent learning curve when it comes to these advanced techniques, and with more experience, we are seeing comparable results for both these modalities. However, given the complexity and time required for the procedure, current practices typically involve preserving ESD for lesions > 2 cm, those having a likelihood of cancer in the superficial submucosa, or those that EMR cannot remove due to underlying fibrosis or post-EMR recurrence.

Srinivasan_Sachin_KS_web.jpg

Barrett’s Refractory to Endoscopic Therapy

Failure of BET is defined as persistent columnar lined epithelium (intestinal metaplasia) with inadequate response, after adequate attempts at endoscopic ablation therapy (after resection) with at least four ablation sessions.¹³ If encountered, special attention must be given to check compliance with proton pump inhibitors (PPIs), previous incomplete resection, and presence of large hiatal hernia. If CE-IM is not achieved after multiple sessions, change of ablative modality is typically considered. In addition, careful examination for visible lesions should be performed and even if a small one is noted, this should be first resected prior to application of any ablative therapy.

Sharma_Prateek_KS_2024_web.jpg

Currently there are no guideline recommendations regarding the preference of one endoscopic modality over another or consideration of potential endoscopic or surgical fundoplication. These modalities primarily rely on technologies available at an institution and the preference of a provider based on their training and experience. Most studies indicate 1-3 sessions (~ 3 months apart) of ablative treatment before achieving CE-IM.
 

Success and Adverse Events of BET

In a recent real-world study of over 27,000 patients with dysplastic BE, 5295 underwent BET. Analysis showed that patients with HGD/EAC who had BET had a significantly lower 3-year mortality (HGD: RR, 0.59; 95%CI, 0.49-0.71; EAC: RR, 0.53; 95% CI, 0.44-0.65) compared with those who did not undergo BET. Esophageal strictures were the most common adverse event and were noted in 6.5%, followed by chest pain (1.8%), upper GI bleeding (0.47%), and esophageal perforation (0.2%).¹⁴

In general, adverse events can be divided into immediate and delayed adverse events. Immediate adverse events typically involve bleeding and perforation that can occur during or shortly after the procedure. These are reported at higher rates with resective modalities compared with ablative therapies. Standard endoscopic techniques involving coagulation grasper or clips can be used to achieve hemostasis. Endoscopic suturing devices offer the ability to contain any perforation. The need for surgical intervention is small and limited to adverse events not detected during the procedure.

Delayed adverse events such as stricture and stenosis are higher for resective modalities (up to 30%), especially when involving more significant than 75% of the esophageal circumference. Post-procedural pain/dysphagia is most common after ablative therapies. Dysphagia reported after any endoscopic therapy should be promptly evaluated, and sequential dilation until the goal esophageal lumen is achieved should be performed every 2-4 weeks.
 

Recurrences and Surveillance After BET

What is established is that recurrences can occur and may be subtle, therefore detailed endoscopic surveillance is required. In a prospective study, recurrence rates of 15%-16% for IM and 3%-5% for any dysplasia were reported, with the majority being in the first 2 years after achieving CE-IM.¹⁵ A systematic review of 21 studies looking at the location of recurrences suggested that the majority (56%) occur in the distal esophagus. Of those that occur in the esophagus, about 80% of them were in the distal 2 cm of the esophagus and only 50% of the recurrences were visible recurrences, thus reiterating the importance of meticulous examination and systematic biopsies.¹⁶

On the contrary, a recent single-center study of 217 patients who had achieved CE-IM with 5.5 years of follow-up demonstrated a 26% and 8% recurrence of IM and dysplasia, respectively. One hundred percent of the recurrence in the esophagus was reported as visible.¹⁷ Therefore, follow-up endoscopy surveillance protocol after CE-IM should still involve meticulous examination, biopsy of visible lesions, and systematic biopsies for non-visible lesions from the original BE segment, similar to those patients who have not needed BET.

Current guidelines based on expert consensus and evidence recommend surveillance after CE-IM based on original most advanced histology:²

1. LGD: 1 year, 3 years, and every 2 years after that.

2. HGD/EAC: 3 months, 6 months, 12 months, and annually after that.

There is no clear guideline on when to stop surveillance since the longest available follow-up is around 10 years, and recurrences are still detected. A potential surveillance endpoint may be based on age and comorbidities, especially those that would preclude a patient from being a candidate for BET.
 

When Should a Patient Be Referred?

BE patients with visible lesions and/or dysplastic changes in the biopsy who would require BET should be considered for referral to high-volume centers. Studies have shown higher success for CE-IM and lower rates of adverse events and recurrences in these patients managed at expert centers. The presence of a multidisciplinary team involving pathologists, surgeons, and oncologists is critical and offers a timely opportunity in case of need for a high-risk patient.

Conclusion

BE is a precursor to EAC, with rising incidence and poor 5-year survival. Endoscopic diagnosis is the gold standard and requires a high-quality examination and biopsies. Based on histopathology, a systematic surveillance and BET plan should be performed to achieve CE-IM in patients with dysplasia. Once CE-IM is achieved, regular surveillance should be performed with careful attention to recurrences and complications from the BET modalities.

Dr. Srinivasan and Dr. Sharma are based at the University of Kansas Medical Center, Kansas City, Kansas, and the Kansas City Veterans Affairs Medical Center, Kansas City, Missouri. Dr. Srinivasan has no relevant disclosures. Dr. Sharma disclosed research grants from ERBE, Ironwood Pharmaceuticals, Olympus, and Medtronic. He has served as a consultant for Takeda, Samsung Bioepis, Olympus, and Lumendi, and reports other funding from Medtronic, Fujifilm Medical Systems USA, and Salix.

References

1. Holmberg D, et al. Incidence and mortality in upper gastrointestinal cancer after negative endoscopy for gastroesophageal reflux disease. Gastroenterology. 2022;162(2):431-438.e4.

2. Shaheen NJ, et al. Diagnosis and management of Barrett’s esophagus: An updated ACG guideline. Am J Gastroenterol. 2022 Apr;117(4):559-587.

3. Pech O, et al. Inter-observer variability in the diagnosis of low-grade dysplasia in pathologists: A comparison between experienced and inexperienced pathologists. Gastrointest Endosc. 2006 Apr;63(5):AB130.

4. Krishnamoorthi R, et al. Factors associated with progression of Barrett’s esophagus: A systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2018 Jul;16(7):1046-1055.e8.

5. Visrodia K, et al. Magnitude of missed esophageal adenocarcinoma after Barrett’s esophagus diagnosis: A systematic review and meta-analysis. Gastroenterology. 2016 Mar;150(3):599-607.e7; quiz e14-5.

6. Perisetti A, Sharma P. Tips for improving the identification of neoplastic visible lesions in Barrett’s esophagus. Gastrointest Endosc. 2023 Feb;97(2):248-250.

7. Gupta N, et al. Longer inspection time is associated with increased detection of high-grade dysplasia and esophageal adenocarcinoma in Barrett’s esophagus. Gastrointest Endosc. 2012 Sep;76(3):531-538.

8. Terheggen G, et al. A randomised trial of endoscopic submucosal dissection versus endoscopic mucosal resection for early Barrett’s neoplasia. Gut. 2017 May;66(5):783-793.

9. Wolfson P, et al. Endoscopic eradication therapy for Barrett’s esophagus-related neoplasia: A final 10-year report from the UK National HALO Radiofrequency Ablation Registry. Gastrointest Endosc. 2022 Aug;96(2):223-233.

10. Rösch T, et al. 1151 Multicenter feasibility study of combined injection and argon plasma coagulation (hybrid-APC) in the ablation therapy of neoplastic Barrett esophagus. Gastrointest Endosc. 2017;85(5):AB154.

11. Knabe M, et al. Radiofrequency ablation versus hybrid argon plasma coagulation in Barrett’s esophagus: A prospective randomised trial. Surg Endosc. 2023;37(10):7803-7811.

12. Van Munster SN, et al. Radiofrequency vapor ablation for Barrett’s esophagus: Feasibility, safety, and proof of concept in a stepwise study with in vitro, animal, and the first in-human application. Endoscopy. 2021 Nov;53(11):1162-1168.

13. Emura F, et al. Rio de Janeiro global consensus on landmarks, definitions, and classifications in Barrett’s esophagus: World Endoscopy Organization Delphi study. Gastroenterology. 2022 Jul;163(1):84-96.e2.

14. Singh RR, et al. Real-world evidence of safety and effectiveness of Barrett’s endoscopic therapy. Gastrointest Endosc. 2023 Aug;98(2):155-161.e1.

15. Wani S, et al. Recurrence Is rare following complete eradication of intestinal metaplasia in patients with Barrett’s esophagus and peaks at 18 months. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2609-2617.e2.

16. Duvvuri A, et al. Mo1273 Location and pattern of recurrences in patients with Barrett’s esophagus after endoscopic therapy: A systematic review and critical analysis of the published literature. Gastrointest Endosc. 2020;91(6):AB410-1.

17. He T, et al. Location and appearance of dysplastic Barrett’s esophagus recurrence after endoscopic eradication therapy: No additional yield from random biopsy sampling neosquamous mucosa. Gastrointest Endosc. 2023 Nov;98(5):722-732.

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.



Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.



Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.



Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.



Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.
 

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.
 

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.



Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.
 

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Rezaie_Ali_CA_web.jpg

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

Wang_Andrew_VA_web.jpg

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Rezaie_Ali_CA_web.jpg

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

Wang_Andrew_VA_web.jpg

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Rezaie_Ali_CA_web.jpg

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

Wang_Andrew_VA_web.jpg

A version of this article appeared on Medscape.com.

A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

CHS, which is triggered by chronic cannabis usage and manifests with GI and autonomic symptoms, is on the rise in the United States, yet underdiagnosis remains a challenge and clinical data are scarce, reported lead update panelist Alberto Rubio Tapia, MD, of Cleveland Clinic, Cleveland, Ohio, and colleagues.

RubioTapia_Alberto_OH_web.jpg

“Although cannabis use has been reported for many decades, some of its unique adverse effects of nausea, vomiting, and abdominal pain, termed CHS, were noted relatively recently,” the panelists wrote in Gastroenterology. “The objective of this article was to help practitioners define the appropriate approach to the diagnosis and management of CHS.”

According to the update, the typical CHS patient is male with a years-long history of daily or near-daily cannabis use. Paradoxically, while cannabis use drives this condition, some patients with CHS report that cannabis use relieves their symptoms.The update describes CHS as a subtype of cyclical vomiting syndrome (CVS), and offers diagnostic criteria for CHS, reproduced below verbatim:

• Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
• Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
• Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

As CHS is a subtype of CVS, the update also provides an outline and management guide for this broader condition, which is characterized by four phases: inter-episodic, prodromal, emetic, and recovery.

During the inter-episodic phase, patients will have minimal or no symptoms, although almost one third will describe dyspepsia or nausea. Prophylactic medications in this period include tricyclics, mitochondrial supplements like CoQ10 and vitamin B12, NK1 antagonists, and anticonvulsants.

The prodromal phase is characterized by abdominal pain and nausea with a duration of 30-90 minutes. During this time patients may have autonomic symptoms like sweating and feeling hot or cold. Psychological symptoms may include feelings of panic and being “out of control.” Abortive medications are appropriate during this period, according to the update, like triptans and antiemetics.

Next comes the emetic phase, in which patients exhibit “relentless vomiting,” retching, abdominal pain, neurological symptoms and extreme thirst. Because an empty stomach may provide relief, inducing emesis may be considered, along with rest in a quiet dark room and supportive care.

Finally, the vomiting subsides during the recovery phase, when it is possible to restart oral intake and resume normal activities.

While this framework may be useful when managing patients with CHS, intervention should be centered around cannabis cessation, according to the update.

“For long-term management, counseling to achieve marijuana cessation and tricyclic antidepressants, such as amitriptyline, are the mainstay of therapy,” Dr. Rubio Tapia and colleagues wrote.

Advising patients to stop cannabis “cold turkey” is not recommended, they added, as this may bring on withdrawal symptoms, and it tends to be ineffective in this population, which has a high recidivism rate.

“Co-management with a psychologist or psychiatrist may be helpful for patients who have a lack of response to standard therapies or extensive psychiatric comorbidity,” the panelists wrote. “Anxiety and depression are very common associated conditions.”

Dr. Rubio Tapia and colleagues concluded with a call for more research.

“Further understanding of CHS pathophysiology and evidence-based therapies are urgently needed,” they wrote.

This update was commissioned and approved by the AGA. The update panelists disclosed relationships with Evoke Pharma, RedHill Biopharma, Takeda, and others.

A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

CHS, which is triggered by chronic cannabis usage and manifests with GI and autonomic symptoms, is on the rise in the United States, yet underdiagnosis remains a challenge and clinical data are scarce, reported lead update panelist Alberto Rubio Tapia, MD, of Cleveland Clinic, Cleveland, Ohio, and colleagues.

RubioTapia_Alberto_OH_web.jpg

“Although cannabis use has been reported for many decades, some of its unique adverse effects of nausea, vomiting, and abdominal pain, termed CHS, were noted relatively recently,” the panelists wrote in Gastroenterology. “The objective of this article was to help practitioners define the appropriate approach to the diagnosis and management of CHS.”

According to the update, the typical CHS patient is male with a years-long history of daily or near-daily cannabis use. Paradoxically, while cannabis use drives this condition, some patients with CHS report that cannabis use relieves their symptoms.The update describes CHS as a subtype of cyclical vomiting syndrome (CVS), and offers diagnostic criteria for CHS, reproduced below verbatim:

• Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
• Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
• Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

As CHS is a subtype of CVS, the update also provides an outline and management guide for this broader condition, which is characterized by four phases: inter-episodic, prodromal, emetic, and recovery.

During the inter-episodic phase, patients will have minimal or no symptoms, although almost one third will describe dyspepsia or nausea. Prophylactic medications in this period include tricyclics, mitochondrial supplements like CoQ10 and vitamin B12, NK1 antagonists, and anticonvulsants.

The prodromal phase is characterized by abdominal pain and nausea with a duration of 30-90 minutes. During this time patients may have autonomic symptoms like sweating and feeling hot or cold. Psychological symptoms may include feelings of panic and being “out of control.” Abortive medications are appropriate during this period, according to the update, like triptans and antiemetics.

Next comes the emetic phase, in which patients exhibit “relentless vomiting,” retching, abdominal pain, neurological symptoms and extreme thirst. Because an empty stomach may provide relief, inducing emesis may be considered, along with rest in a quiet dark room and supportive care.

Finally, the vomiting subsides during the recovery phase, when it is possible to restart oral intake and resume normal activities.

While this framework may be useful when managing patients with CHS, intervention should be centered around cannabis cessation, according to the update.

“For long-term management, counseling to achieve marijuana cessation and tricyclic antidepressants, such as amitriptyline, are the mainstay of therapy,” Dr. Rubio Tapia and colleagues wrote.

Advising patients to stop cannabis “cold turkey” is not recommended, they added, as this may bring on withdrawal symptoms, and it tends to be ineffective in this population, which has a high recidivism rate.

“Co-management with a psychologist or psychiatrist may be helpful for patients who have a lack of response to standard therapies or extensive psychiatric comorbidity,” the panelists wrote. “Anxiety and depression are very common associated conditions.”

Dr. Rubio Tapia and colleagues concluded with a call for more research.

“Further understanding of CHS pathophysiology and evidence-based therapies are urgently needed,” they wrote.

This update was commissioned and approved by the AGA. The update panelists disclosed relationships with Evoke Pharma, RedHill Biopharma, Takeda, and others.

A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

CHS, which is triggered by chronic cannabis usage and manifests with GI and autonomic symptoms, is on the rise in the United States, yet underdiagnosis remains a challenge and clinical data are scarce, reported lead update panelist Alberto Rubio Tapia, MD, of Cleveland Clinic, Cleveland, Ohio, and colleagues.

RubioTapia_Alberto_OH_web.jpg

“Although cannabis use has been reported for many decades, some of its unique adverse effects of nausea, vomiting, and abdominal pain, termed CHS, were noted relatively recently,” the panelists wrote in Gastroenterology. “The objective of this article was to help practitioners define the appropriate approach to the diagnosis and management of CHS.”

According to the update, the typical CHS patient is male with a years-long history of daily or near-daily cannabis use. Paradoxically, while cannabis use drives this condition, some patients with CHS report that cannabis use relieves their symptoms.The update describes CHS as a subtype of cyclical vomiting syndrome (CVS), and offers diagnostic criteria for CHS, reproduced below verbatim:

• Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
• Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
• Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

As CHS is a subtype of CVS, the update also provides an outline and management guide for this broader condition, which is characterized by four phases: inter-episodic, prodromal, emetic, and recovery.

During the inter-episodic phase, patients will have minimal or no symptoms, although almost one third will describe dyspepsia or nausea. Prophylactic medications in this period include tricyclics, mitochondrial supplements like CoQ10 and vitamin B12, NK1 antagonists, and anticonvulsants.

The prodromal phase is characterized by abdominal pain and nausea with a duration of 30-90 minutes. During this time patients may have autonomic symptoms like sweating and feeling hot or cold. Psychological symptoms may include feelings of panic and being “out of control.” Abortive medications are appropriate during this period, according to the update, like triptans and antiemetics.

Next comes the emetic phase, in which patients exhibit “relentless vomiting,” retching, abdominal pain, neurological symptoms and extreme thirst. Because an empty stomach may provide relief, inducing emesis may be considered, along with rest in a quiet dark room and supportive care.

Finally, the vomiting subsides during the recovery phase, when it is possible to restart oral intake and resume normal activities.

While this framework may be useful when managing patients with CHS, intervention should be centered around cannabis cessation, according to the update.

“For long-term management, counseling to achieve marijuana cessation and tricyclic antidepressants, such as amitriptyline, are the mainstay of therapy,” Dr. Rubio Tapia and colleagues wrote.

Advising patients to stop cannabis “cold turkey” is not recommended, they added, as this may bring on withdrawal symptoms, and it tends to be ineffective in this population, which has a high recidivism rate.

“Co-management with a psychologist or psychiatrist may be helpful for patients who have a lack of response to standard therapies or extensive psychiatric comorbidity,” the panelists wrote. “Anxiety and depression are very common associated conditions.”

Dr. Rubio Tapia and colleagues concluded with a call for more research.

“Further understanding of CHS pathophysiology and evidence-based therapies are urgently needed,” they wrote.

This update was commissioned and approved by the AGA. The update panelists disclosed relationships with Evoke Pharma, RedHill Biopharma, Takeda, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Nagula_Satish_NY_web.jpg

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Nagula_Satish_NY_web.jpg

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

Nagula_Satish_NY_web.jpg

“Defining what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures defining a high-quality upper endoscopic examination is one of the first steps for assessing quality.”
 

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.
 

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-definition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.
 

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.
 

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”
 

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujifilm USA, Mahana Therapeutics, and others.

The global prevalence of Helicobacter pylori (H. pylori) infection in adults has fallen more than 15% over the past three decades, and gastric cancer incidence appears to be falling in turn, according to investigators.

These findings suggest that decreasing H. pylori prevalence does indeed reduce rates of gastric cancer, although large-scale clinical trials are needed to solidify confidence in this apparent relationship, reported lead author Yi Chun Chen, PhD, of National Taiwan University, Taipei, and colleagues.

“Eradication of H. pylori infection heals chronic active gastritis and peptic ulcer disease and reduces the risk of peptic ulcer bleeding in aspirin users and the risk of gastric cancer in infected individuals,” the investigators wrote in Gastroenterology. “However, whether reduction of the prevalence of H. pylori is associated with a reduction of the incidence of gastric cancer at the population level remains uncertain.”

According to several previous meta-analyses, the global rate of H. pylori infection has been in a downtrend, but Dr. Chen and colleagues pointed out several limitations of these publications, including scarcity of recent data, insufficiently representative data, inconsistent diagnostic methods, and lack of adjustment for socioeconomic status.

“We therefore conducted this comprehensive systematic review and meta-analysis, including healthy individuals recruited in hospital-based studies, to provide an updated global prevalence and the secular trend of H. pylori infection,” the investigators wrote, noting that they leveraged meta-regression analysis to “identify factors affecting heterogeneity of the prevalence,” and concurrently evaluated the corresponding global incidence of gastric cancer.

Their dataset, which included 1,748 articles from 111 countries, suggested that the global rate of H. pylori is indeed in a downtrend.

From a crude global prevalence of 52.6% prior to 1990, the rate of H. pylori decreased to 43.9% among adults in 2015-2022, but was “still as high as” 35.1% among children and adolescents in the same 2015-2022 period. Multivariate regression analysis showed that prevalence decreased significantly, by 15.9%, among adults, but not in children and adolescents.

“The significant reduction of H. pylori prevalence in adults can be explained by the improvement of socioeconomic status, cleaner water supply, better sanitation and hygiene status, and widening of indication for eradication therapy,” Dr. Chen and colleagues wrote. “The higher prevalence in adults than in children/adolescents is explained by the cohort effect because most H. pylori infection is acquired in childhood.”

Global incidence of gastric cancer among both male and female individuals declined approximately in parallel with decreasing prevalence of H. pylori. Rates of gastric cancer decreased most in high-incidence countries such as Brazil, Japan, and China.

“These studies collectively provide evidence for the causal association of H. pylori infection and gastric cancer and that elimination of this bacterium can prevent the development of gastric cancer,” the investigators wrote.

Still, more work is needed.

“Future prospective studies should be conducted to confirm whether public health interventions or mass screening and eradication of H. pylori infection to reduce its prevalence may reduce the incidence of gastric cancer at population level,” Dr. Chen and colleagues concluded. “Besides, it is also important to consider the potential adverse consequences of H. pylori eradication, such as emergence of antibiotic resistance. The benefit-to-harm ratio and cost-effectiveness should also be taken into account.”

The study was funded by the National Taiwan University Hospital, the Taiwan Ministry of Science and Technology, the Taiwan Ministry of Health and Welfare, and others. The investigators disclosed no conflicts of interest.

The global prevalence of Helicobacter pylori (H. pylori) infection in adults has fallen more than 15% over the past three decades, and gastric cancer incidence appears to be falling in turn, according to investigators.

These findings suggest that decreasing H. pylori prevalence does indeed reduce rates of gastric cancer, although large-scale clinical trials are needed to solidify confidence in this apparent relationship, reported lead author Yi Chun Chen, PhD, of National Taiwan University, Taipei, and colleagues.

“Eradication of H. pylori infection heals chronic active gastritis and peptic ulcer disease and reduces the risk of peptic ulcer bleeding in aspirin users and the risk of gastric cancer in infected individuals,” the investigators wrote in Gastroenterology. “However, whether reduction of the prevalence of H. pylori is associated with a reduction of the incidence of gastric cancer at the population level remains uncertain.”

According to several previous meta-analyses, the global rate of H. pylori infection has been in a downtrend, but Dr. Chen and colleagues pointed out several limitations of these publications, including scarcity of recent data, insufficiently representative data, inconsistent diagnostic methods, and lack of adjustment for socioeconomic status.

“We therefore conducted this comprehensive systematic review and meta-analysis, including healthy individuals recruited in hospital-based studies, to provide an updated global prevalence and the secular trend of H. pylori infection,” the investigators wrote, noting that they leveraged meta-regression analysis to “identify factors affecting heterogeneity of the prevalence,” and concurrently evaluated the corresponding global incidence of gastric cancer.

Their dataset, which included 1,748 articles from 111 countries, suggested that the global rate of H. pylori is indeed in a downtrend.

From a crude global prevalence of 52.6% prior to 1990, the rate of H. pylori decreased to 43.9% among adults in 2015-2022, but was “still as high as” 35.1% among children and adolescents in the same 2015-2022 period. Multivariate regression analysis showed that prevalence decreased significantly, by 15.9%, among adults, but not in children and adolescents.

“The significant reduction of H. pylori prevalence in adults can be explained by the improvement of socioeconomic status, cleaner water supply, better sanitation and hygiene status, and widening of indication for eradication therapy,” Dr. Chen and colleagues wrote. “The higher prevalence in adults than in children/adolescents is explained by the cohort effect because most H. pylori infection is acquired in childhood.”

Global incidence of gastric cancer among both male and female individuals declined approximately in parallel with decreasing prevalence of H. pylori. Rates of gastric cancer decreased most in high-incidence countries such as Brazil, Japan, and China.

“These studies collectively provide evidence for the causal association of H. pylori infection and gastric cancer and that elimination of this bacterium can prevent the development of gastric cancer,” the investigators wrote.

Still, more work is needed.

“Future prospective studies should be conducted to confirm whether public health interventions or mass screening and eradication of H. pylori infection to reduce its prevalence may reduce the incidence of gastric cancer at population level,” Dr. Chen and colleagues concluded. “Besides, it is also important to consider the potential adverse consequences of H. pylori eradication, such as emergence of antibiotic resistance. The benefit-to-harm ratio and cost-effectiveness should also be taken into account.”

The study was funded by the National Taiwan University Hospital, the Taiwan Ministry of Science and Technology, the Taiwan Ministry of Health and Welfare, and others. The investigators disclosed no conflicts of interest.

The global prevalence of Helicobacter pylori (H. pylori) infection in adults has fallen more than 15% over the past three decades, and gastric cancer incidence appears to be falling in turn, according to investigators.

These findings suggest that decreasing H. pylori prevalence does indeed reduce rates of gastric cancer, although large-scale clinical trials are needed to solidify confidence in this apparent relationship, reported lead author Yi Chun Chen, PhD, of National Taiwan University, Taipei, and colleagues.

“Eradication of H. pylori infection heals chronic active gastritis and peptic ulcer disease and reduces the risk of peptic ulcer bleeding in aspirin users and the risk of gastric cancer in infected individuals,” the investigators wrote in Gastroenterology. “However, whether reduction of the prevalence of H. pylori is associated with a reduction of the incidence of gastric cancer at the population level remains uncertain.”

According to several previous meta-analyses, the global rate of H. pylori infection has been in a downtrend, but Dr. Chen and colleagues pointed out several limitations of these publications, including scarcity of recent data, insufficiently representative data, inconsistent diagnostic methods, and lack of adjustment for socioeconomic status.

“We therefore conducted this comprehensive systematic review and meta-analysis, including healthy individuals recruited in hospital-based studies, to provide an updated global prevalence and the secular trend of H. pylori infection,” the investigators wrote, noting that they leveraged meta-regression analysis to “identify factors affecting heterogeneity of the prevalence,” and concurrently evaluated the corresponding global incidence of gastric cancer.

Their dataset, which included 1,748 articles from 111 countries, suggested that the global rate of H. pylori is indeed in a downtrend.

From a crude global prevalence of 52.6% prior to 1990, the rate of H. pylori decreased to 43.9% among adults in 2015-2022, but was “still as high as” 35.1% among children and adolescents in the same 2015-2022 period. Multivariate regression analysis showed that prevalence decreased significantly, by 15.9%, among adults, but not in children and adolescents.

“The significant reduction of H. pylori prevalence in adults can be explained by the improvement of socioeconomic status, cleaner water supply, better sanitation and hygiene status, and widening of indication for eradication therapy,” Dr. Chen and colleagues wrote. “The higher prevalence in adults than in children/adolescents is explained by the cohort effect because most H. pylori infection is acquired in childhood.”

Global incidence of gastric cancer among both male and female individuals declined approximately in parallel with decreasing prevalence of H. pylori. Rates of gastric cancer decreased most in high-incidence countries such as Brazil, Japan, and China.

“These studies collectively provide evidence for the causal association of H. pylori infection and gastric cancer and that elimination of this bacterium can prevent the development of gastric cancer,” the investigators wrote.

Still, more work is needed.

“Future prospective studies should be conducted to confirm whether public health interventions or mass screening and eradication of H. pylori infection to reduce its prevalence may reduce the incidence of gastric cancer at population level,” Dr. Chen and colleagues concluded. “Besides, it is also important to consider the potential adverse consequences of H. pylori eradication, such as emergence of antibiotic resistance. The benefit-to-harm ratio and cost-effectiveness should also be taken into account.”

The study was funded by the National Taiwan University Hospital, the Taiwan Ministry of Science and Technology, the Taiwan Ministry of Health and Welfare, and others. The investigators disclosed no conflicts of interest.

The US Food and Drug Administration approvals of dupilumab (Dupixent, Regeneron/Sanofi) for adults and children with eosinophilic esophagitis (EoE) affirmed the safety and efficacy of the drug, which is the first product indicated specifically for treatment of this disease.

The recent expanded approval for its use in kids aged 1 year and older imply that clinicians can prescribe it for just about any patient with the immune disorder.

But is dupilumab right for everyone?
 

What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

The first approval for EoE, on May 22, 2022, for adults and children aged 12 years and older weighing at least 40 kg, was based on data from 321 participants in the first two parts of a three-part phase 3 trial involving patients with EoE despite 8 weeks of high-dose proton pump inhibitor (PPI) therapy and with substantial symptom burden.

At 24 weeks, histologic remission occurred in 60% of patients in Part A of the trial and 59% in Part B who received a weekly 300-mg dose of dupilumab compared with 5% and 6% taking placebo. Additionally, Part A and B participants taking the drug weekly experienced a 69% and 64% reduction in disease symptoms, respectively, vs 32% and 41% for placebo. The drug also outperformed placebo in reducing patients’ esophageal eosinophilic counts and abnormal endoscopic findings.

The second approval, on January 25, 2024, for children aged 1 year and older weighing at least 15 kg, was based on data from a two-part, placebo-controlled trial involving 102 children, ages 1-11 years, with EoE. The study involved a 16-week treatment period and a 36-week extended period during which eligible children from the dupilumab group continued to receive their weight-based dose level and those who were on placebo switched to active treatment. The trial showed that a greater proportion of children taking the drug achieved histological remission.
 

A Major Advance but Temper Expectations

Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations,” Philip Katz, MD, AGAF, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York City, said in an interview. “I’ve been using it since The New England Journal of Medicine paper was published about a year and a half ago , and as a slow adopter, I like it.”

Dr. Katz and his colleagues have been prescribing dupilumab mainly for patients who haven’t responded to other medications, mainly PPIs and steroids.

“We start people on it without stopping anything else,” Dr. Katz said. “Then, as symptoms evolve and people have a positive response, we stop the other medications. For example, in one patient who did very well on the drug, we stopped his steroids and now, we’re weaning him off his PPI. It’s a process. This is not a disease where you can rush people.”

The tempered approach is in part because of payer issues, he noted.

“It’s very difficult to get it reimbursed in the US if you haven’t tried something else first,” Dr. Katz said. “And because it’s still relatively new in this field, standard treatment is still used frequently.”

Although Dr. Katz has had “incredible success” with dupilumab so far, “nothing should be considered a miracle drug,” he said. “A couple of people have had injection reactions, and one person couldn’t tolerate the drug. So, while it seems to have an excellent response rate, it’s not 100%. Like any new drug, it will have to find its true success rate.”
 

Taking a Step-Up Approach

Like Dr. Katz, Evan Dellon, MD, MPH, AGAF, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, North Carolina, is enthusiastic about dupilumab.

“It’s a boon to the field, and now, some real-world data are coming out and looking very much like the clinical trial data, which are reassuring,” said Dr. Dellon, a coauthor of The New England Journal of Medicine paper.

It’s been a “game changer,” particularly for people who weren’t doing well with their current treatments, he said. “In my practice, I’ve been seeing a lowish response rate for PPIs, and about 30%-40% not responding to topical steroids, since we don’t have a standard formulation for that. The diet elimination therapy is effective if people can do it well and adhere to it. But there’s a group of people who don’t respond, and probably, a larger group who can’t really do that treatment long term. So, the drug has been fantastic for those patients.”

Although the drug is approved for patients aged 1 year and older with no caveats, “it’s not the right medicine for every patient,” he said. “Patients in the clinical trials had EoE for 5 years, many of them were treatment refractory, and just under half had dilations and strictures,” he said. “They represent a certain group of patients.”

Dr. Dellon is taking a “step-up approach” to EoE treatment, first trying the standard interventions — PPIs, steroids, and an elimination diet — that many patients do respond to.

For new patients who choose medication therapy, he prescribes PPIs and then topical steroids and then steps up to dupilumab for patients who aren’t responding or who have a strong preference for starting the drug early.

In addition to EoE, the drug is approved for certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. As such, Dr. Dellon said that he will try dupilumab early on in patients with multiple atopic conditions, such as asthma, eczema, or nasal disease.

“Even if their EoE is not that severe, those patients can still benefit from a more streamlined systemic therapy,” he said.
 

Challenges and Questions Still Remain

Not surprisingly, both Dr. Katz and Dr. Dellon pointed to dupilumab’s cost and the related challenge of convincing insurance companies to cover the drug as major challenges to more widespread use. The lack of long-term data also poses a challenge.

Side effects, which often stand in the way of the use of a new drug, are not an issue, for the most part, at least in the short term, according to Dr. Dellon. The most common side effects are discomfort, redness at the injection site, and pain related to the injection.

“Keeping the medication out of the refrigerator for a bit to bring it up to room temperature can help, as can doing the injection in the lower abdomen,” he said. “Otherwise, it’s well tolerated, with no side effects that are unique to EoE.”

Data from the third part of the clinical trial, which followed patients from weeks 24-52 of treatment, indicated that improvements in histological, symptomatic, endoscopic, and molecular features of EoE among patients taking weekly dupilumab continued or improved.

In my practice, “my observations have been that people are maintaining their responses,” said Dr. Dellon, a coauthor of the paper on the study’s third part.

However, one critical question is whether the dose intensity and/or frequency can be decreased over time without reducing the response rate.

“Hopefully, we’ll start getting data on that in the next year or two,” Dr. Dellon said. “It’s hard to do that yet because the drug has only been out for a year or year and a half, and people are just getting to that year of the initial dosing.”

Another question is how to use the drug in people who are different from the clinical trial population, such as those who have been responding to other therapies but want to switch, and people who are newly diagnosed but who have severe disease. Can the drug be used earlier in these populations?

Dr. Dellon would like to see a study that utilizes the new EoE index of severity metric to focus specifically on dupilumab use in patients with severe disease.

Early findings from his recent real-world study of 46 patients with severe disease who would not have qualified for the clinical trials found histologic, endoscopic, and symptom improvement in 91% of patients with refractory and fibrostenotic EoE after 6 months of dupilumab treatment.

While women tend to be well represented in the clinical trial, the drug needs to be tested in a more diverse population, Dr. Dellon noted. Research is underway looking at dupilumab effectiveness in people with different race/ethnicities.

EoE is more common among White people but that may be the result of a “detection issue,” he said. “When clinicians see a Black or Hispanic patient with dysphagia, for example, they may not be thinking of EoE. And there are also some data suggesting that EoE presents slightly differently in non-White populations, which again could decrease the suspicion for it. This is an area we need to learn more about.”
 

Don’t ‘Abandon’ Current Interventions

“We’ve got an exciting drug that is going to help a lot of people with a complex disease,” Dr. Katz said. “But we should not forget that there are other interventions that have been successful, and quite frankly, they don’t need to be abandoned.”

“Learn about the drug if you’ve never used it,” he advised. “Read the studies so you understand who the patients were as a baseline for where you’re going to use it. Be prepared to do the appropriate paperwork requirements to get approvals from insurers. And look for more literature because it’s coming.”

“Overall, dupilumab has really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” Dr. Dellon said. “That’s the natural place for the medication to go at this point.”

Dr. Katz is a consultant to Phathom Pharma, Sebela Pharma, Medpace (not active), and Medtronic.

Dr. Dellon received research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda. He served as a consultant to Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, and Upstream Bio. He also received educational grants from Allakos, Aqilion, Holoclara, and Invea.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration approvals of dupilumab (Dupixent, Regeneron/Sanofi) for adults and children with eosinophilic esophagitis (EoE) affirmed the safety and efficacy of the drug, which is the first product indicated specifically for treatment of this disease.

The recent expanded approval for its use in kids aged 1 year and older imply that clinicians can prescribe it for just about any patient with the immune disorder.

But is dupilumab right for everyone?
 

What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

The first approval for EoE, on May 22, 2022, for adults and children aged 12 years and older weighing at least 40 kg, was based on data from 321 participants in the first two parts of a three-part phase 3 trial involving patients with EoE despite 8 weeks of high-dose proton pump inhibitor (PPI) therapy and with substantial symptom burden.

At 24 weeks, histologic remission occurred in 60% of patients in Part A of the trial and 59% in Part B who received a weekly 300-mg dose of dupilumab compared with 5% and 6% taking placebo. Additionally, Part A and B participants taking the drug weekly experienced a 69% and 64% reduction in disease symptoms, respectively, vs 32% and 41% for placebo. The drug also outperformed placebo in reducing patients’ esophageal eosinophilic counts and abnormal endoscopic findings.

The second approval, on January 25, 2024, for children aged 1 year and older weighing at least 15 kg, was based on data from a two-part, placebo-controlled trial involving 102 children, ages 1-11 years, with EoE. The study involved a 16-week treatment period and a 36-week extended period during which eligible children from the dupilumab group continued to receive their weight-based dose level and those who were on placebo switched to active treatment. The trial showed that a greater proportion of children taking the drug achieved histological remission.
 

A Major Advance but Temper Expectations

Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations,” Philip Katz, MD, AGAF, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York City, said in an interview. “I’ve been using it since The New England Journal of Medicine paper was published about a year and a half ago , and as a slow adopter, I like it.”

Dr. Katz and his colleagues have been prescribing dupilumab mainly for patients who haven’t responded to other medications, mainly PPIs and steroids.

“We start people on it without stopping anything else,” Dr. Katz said. “Then, as symptoms evolve and people have a positive response, we stop the other medications. For example, in one patient who did very well on the drug, we stopped his steroids and now, we’re weaning him off his PPI. It’s a process. This is not a disease where you can rush people.”

The tempered approach is in part because of payer issues, he noted.

“It’s very difficult to get it reimbursed in the US if you haven’t tried something else first,” Dr. Katz said. “And because it’s still relatively new in this field, standard treatment is still used frequently.”

Although Dr. Katz has had “incredible success” with dupilumab so far, “nothing should be considered a miracle drug,” he said. “A couple of people have had injection reactions, and one person couldn’t tolerate the drug. So, while it seems to have an excellent response rate, it’s not 100%. Like any new drug, it will have to find its true success rate.”
 

Taking a Step-Up Approach

Like Dr. Katz, Evan Dellon, MD, MPH, AGAF, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, North Carolina, is enthusiastic about dupilumab.

“It’s a boon to the field, and now, some real-world data are coming out and looking very much like the clinical trial data, which are reassuring,” said Dr. Dellon, a coauthor of The New England Journal of Medicine paper.

It’s been a “game changer,” particularly for people who weren’t doing well with their current treatments, he said. “In my practice, I’ve been seeing a lowish response rate for PPIs, and about 30%-40% not responding to topical steroids, since we don’t have a standard formulation for that. The diet elimination therapy is effective if people can do it well and adhere to it. But there’s a group of people who don’t respond, and probably, a larger group who can’t really do that treatment long term. So, the drug has been fantastic for those patients.”

Although the drug is approved for patients aged 1 year and older with no caveats, “it’s not the right medicine for every patient,” he said. “Patients in the clinical trials had EoE for 5 years, many of them were treatment refractory, and just under half had dilations and strictures,” he said. “They represent a certain group of patients.”

Dr. Dellon is taking a “step-up approach” to EoE treatment, first trying the standard interventions — PPIs, steroids, and an elimination diet — that many patients do respond to.

For new patients who choose medication therapy, he prescribes PPIs and then topical steroids and then steps up to dupilumab for patients who aren’t responding or who have a strong preference for starting the drug early.

In addition to EoE, the drug is approved for certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. As such, Dr. Dellon said that he will try dupilumab early on in patients with multiple atopic conditions, such as asthma, eczema, or nasal disease.

“Even if their EoE is not that severe, those patients can still benefit from a more streamlined systemic therapy,” he said.
 

Challenges and Questions Still Remain

Not surprisingly, both Dr. Katz and Dr. Dellon pointed to dupilumab’s cost and the related challenge of convincing insurance companies to cover the drug as major challenges to more widespread use. The lack of long-term data also poses a challenge.

Side effects, which often stand in the way of the use of a new drug, are not an issue, for the most part, at least in the short term, according to Dr. Dellon. The most common side effects are discomfort, redness at the injection site, and pain related to the injection.

“Keeping the medication out of the refrigerator for a bit to bring it up to room temperature can help, as can doing the injection in the lower abdomen,” he said. “Otherwise, it’s well tolerated, with no side effects that are unique to EoE.”

Data from the third part of the clinical trial, which followed patients from weeks 24-52 of treatment, indicated that improvements in histological, symptomatic, endoscopic, and molecular features of EoE among patients taking weekly dupilumab continued or improved.

In my practice, “my observations have been that people are maintaining their responses,” said Dr. Dellon, a coauthor of the paper on the study’s third part.

However, one critical question is whether the dose intensity and/or frequency can be decreased over time without reducing the response rate.

“Hopefully, we’ll start getting data on that in the next year or two,” Dr. Dellon said. “It’s hard to do that yet because the drug has only been out for a year or year and a half, and people are just getting to that year of the initial dosing.”

Another question is how to use the drug in people who are different from the clinical trial population, such as those who have been responding to other therapies but want to switch, and people who are newly diagnosed but who have severe disease. Can the drug be used earlier in these populations?

Dr. Dellon would like to see a study that utilizes the new EoE index of severity metric to focus specifically on dupilumab use in patients with severe disease.

Early findings from his recent real-world study of 46 patients with severe disease who would not have qualified for the clinical trials found histologic, endoscopic, and symptom improvement in 91% of patients with refractory and fibrostenotic EoE after 6 months of dupilumab treatment.

While women tend to be well represented in the clinical trial, the drug needs to be tested in a more diverse population, Dr. Dellon noted. Research is underway looking at dupilumab effectiveness in people with different race/ethnicities.

EoE is more common among White people but that may be the result of a “detection issue,” he said. “When clinicians see a Black or Hispanic patient with dysphagia, for example, they may not be thinking of EoE. And there are also some data suggesting that EoE presents slightly differently in non-White populations, which again could decrease the suspicion for it. This is an area we need to learn more about.”
 

Don’t ‘Abandon’ Current Interventions

“We’ve got an exciting drug that is going to help a lot of people with a complex disease,” Dr. Katz said. “But we should not forget that there are other interventions that have been successful, and quite frankly, they don’t need to be abandoned.”

“Learn about the drug if you’ve never used it,” he advised. “Read the studies so you understand who the patients were as a baseline for where you’re going to use it. Be prepared to do the appropriate paperwork requirements to get approvals from insurers. And look for more literature because it’s coming.”

“Overall, dupilumab has really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” Dr. Dellon said. “That’s the natural place for the medication to go at this point.”

Dr. Katz is a consultant to Phathom Pharma, Sebela Pharma, Medpace (not active), and Medtronic.

Dr. Dellon received research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda. He served as a consultant to Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, and Upstream Bio. He also received educational grants from Allakos, Aqilion, Holoclara, and Invea.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration approvals of dupilumab (Dupixent, Regeneron/Sanofi) for adults and children with eosinophilic esophagitis (EoE) affirmed the safety and efficacy of the drug, which is the first product indicated specifically for treatment of this disease.

The recent expanded approval for its use in kids aged 1 year and older imply that clinicians can prescribe it for just about any patient with the immune disorder.

But is dupilumab right for everyone?
 

What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

The first approval for EoE, on May 22, 2022, for adults and children aged 12 years and older weighing at least 40 kg, was based on data from 321 participants in the first two parts of a three-part phase 3 trial involving patients with EoE despite 8 weeks of high-dose proton pump inhibitor (PPI) therapy and with substantial symptom burden.

At 24 weeks, histologic remission occurred in 60% of patients in Part A of the trial and 59% in Part B who received a weekly 300-mg dose of dupilumab compared with 5% and 6% taking placebo. Additionally, Part A and B participants taking the drug weekly experienced a 69% and 64% reduction in disease symptoms, respectively, vs 32% and 41% for placebo. The drug also outperformed placebo in reducing patients’ esophageal eosinophilic counts and abnormal endoscopic findings.

The second approval, on January 25, 2024, for children aged 1 year and older weighing at least 15 kg, was based on data from a two-part, placebo-controlled trial involving 102 children, ages 1-11 years, with EoE. The study involved a 16-week treatment period and a 36-week extended period during which eligible children from the dupilumab group continued to receive their weight-based dose level and those who were on placebo switched to active treatment. The trial showed that a greater proportion of children taking the drug achieved histological remission.
 

A Major Advance but Temper Expectations

Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations,” Philip Katz, MD, AGAF, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York City, said in an interview. “I’ve been using it since The New England Journal of Medicine paper was published about a year and a half ago , and as a slow adopter, I like it.”

Dr. Katz and his colleagues have been prescribing dupilumab mainly for patients who haven’t responded to other medications, mainly PPIs and steroids.

“We start people on it without stopping anything else,” Dr. Katz said. “Then, as symptoms evolve and people have a positive response, we stop the other medications. For example, in one patient who did very well on the drug, we stopped his steroids and now, we’re weaning him off his PPI. It’s a process. This is not a disease where you can rush people.”

The tempered approach is in part because of payer issues, he noted.

“It’s very difficult to get it reimbursed in the US if you haven’t tried something else first,” Dr. Katz said. “And because it’s still relatively new in this field, standard treatment is still used frequently.”

Although Dr. Katz has had “incredible success” with dupilumab so far, “nothing should be considered a miracle drug,” he said. “A couple of people have had injection reactions, and one person couldn’t tolerate the drug. So, while it seems to have an excellent response rate, it’s not 100%. Like any new drug, it will have to find its true success rate.”
 

Taking a Step-Up Approach

Like Dr. Katz, Evan Dellon, MD, MPH, AGAF, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, North Carolina, is enthusiastic about dupilumab.

“It’s a boon to the field, and now, some real-world data are coming out and looking very much like the clinical trial data, which are reassuring,” said Dr. Dellon, a coauthor of The New England Journal of Medicine paper.

It’s been a “game changer,” particularly for people who weren’t doing well with their current treatments, he said. “In my practice, I’ve been seeing a lowish response rate for PPIs, and about 30%-40% not responding to topical steroids, since we don’t have a standard formulation for that. The diet elimination therapy is effective if people can do it well and adhere to it. But there’s a group of people who don’t respond, and probably, a larger group who can’t really do that treatment long term. So, the drug has been fantastic for those patients.”

Although the drug is approved for patients aged 1 year and older with no caveats, “it’s not the right medicine for every patient,” he said. “Patients in the clinical trials had EoE for 5 years, many of them were treatment refractory, and just under half had dilations and strictures,” he said. “They represent a certain group of patients.”

Dr. Dellon is taking a “step-up approach” to EoE treatment, first trying the standard interventions — PPIs, steroids, and an elimination diet — that many patients do respond to.

For new patients who choose medication therapy, he prescribes PPIs and then topical steroids and then steps up to dupilumab for patients who aren’t responding or who have a strong preference for starting the drug early.

In addition to EoE, the drug is approved for certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. As such, Dr. Dellon said that he will try dupilumab early on in patients with multiple atopic conditions, such as asthma, eczema, or nasal disease.

“Even if their EoE is not that severe, those patients can still benefit from a more streamlined systemic therapy,” he said.
 

Challenges and Questions Still Remain

Not surprisingly, both Dr. Katz and Dr. Dellon pointed to dupilumab’s cost and the related challenge of convincing insurance companies to cover the drug as major challenges to more widespread use. The lack of long-term data also poses a challenge.

Side effects, which often stand in the way of the use of a new drug, are not an issue, for the most part, at least in the short term, according to Dr. Dellon. The most common side effects are discomfort, redness at the injection site, and pain related to the injection.

“Keeping the medication out of the refrigerator for a bit to bring it up to room temperature can help, as can doing the injection in the lower abdomen,” he said. “Otherwise, it’s well tolerated, with no side effects that are unique to EoE.”

Data from the third part of the clinical trial, which followed patients from weeks 24-52 of treatment, indicated that improvements in histological, symptomatic, endoscopic, and molecular features of EoE among patients taking weekly dupilumab continued or improved.

In my practice, “my observations have been that people are maintaining their responses,” said Dr. Dellon, a coauthor of the paper on the study’s third part.

However, one critical question is whether the dose intensity and/or frequency can be decreased over time without reducing the response rate.

“Hopefully, we’ll start getting data on that in the next year or two,” Dr. Dellon said. “It’s hard to do that yet because the drug has only been out for a year or year and a half, and people are just getting to that year of the initial dosing.”

Another question is how to use the drug in people who are different from the clinical trial population, such as those who have been responding to other therapies but want to switch, and people who are newly diagnosed but who have severe disease. Can the drug be used earlier in these populations?

Dr. Dellon would like to see a study that utilizes the new EoE index of severity metric to focus specifically on dupilumab use in patients with severe disease.

Early findings from his recent real-world study of 46 patients with severe disease who would not have qualified for the clinical trials found histologic, endoscopic, and symptom improvement in 91% of patients with refractory and fibrostenotic EoE after 6 months of dupilumab treatment.

While women tend to be well represented in the clinical trial, the drug needs to be tested in a more diverse population, Dr. Dellon noted. Research is underway looking at dupilumab effectiveness in people with different race/ethnicities.

EoE is more common among White people but that may be the result of a “detection issue,” he said. “When clinicians see a Black or Hispanic patient with dysphagia, for example, they may not be thinking of EoE. And there are also some data suggesting that EoE presents slightly differently in non-White populations, which again could decrease the suspicion for it. This is an area we need to learn more about.”
 

Don’t ‘Abandon’ Current Interventions

“We’ve got an exciting drug that is going to help a lot of people with a complex disease,” Dr. Katz said. “But we should not forget that there are other interventions that have been successful, and quite frankly, they don’t need to be abandoned.”

“Learn about the drug if you’ve never used it,” he advised. “Read the studies so you understand who the patients were as a baseline for where you’re going to use it. Be prepared to do the appropriate paperwork requirements to get approvals from insurers. And look for more literature because it’s coming.”

“Overall, dupilumab has really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” Dr. Dellon said. “That’s the natural place for the medication to go at this point.”

Dr. Katz is a consultant to Phathom Pharma, Sebela Pharma, Medpace (not active), and Medtronic.

Dr. Dellon received research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda. He served as a consultant to Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, and Upstream Bio. He also received educational grants from Allakos, Aqilion, Holoclara, and Invea.

A version of this article appeared on Medscape.com.