ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.
In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.
For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.
In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.
In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.
Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).
The differences were highly statistically significant, Dr. Gralnek said.
Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.
Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.
Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.
The study was sponsored by EndoChoice.
Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.