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FUSE colonoscopy produced better adenoma detection, miss rates vs. TFV
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ORLANDO, Fla. — Colonoscopies performed using a new, 330-degree colonoscope resulted in significantly improved detection and miss rates for adenomas compared with standard colonoscopes, according to data presented at Digestive Disease Week.
In a prospective, multicenter, international study, researchers administered tandem colonoscopies via traditional forward-viewing (TFV) and full spectrum endoscopy (FUSE, EndoChoice) to 185 adult patients (mean age 55.8 years) between January 2012 and March 2013. The FUSE device is technically identical to standard colonoscopes, but allows for 330-degree viewing compared with 170 degrees with TFV. Patients were randomly assigned to either TFV followed by FUSE (n=88) or FUSE followed by TFV (n=97).
“We all know that traditional forward-viewing colonoscopy is considered the gold standard for detecting adenomas as well as early cancers,” researcher Ian M. Gralnek, MD, senior physician in the gastroenterology department at Rambam Health Care Campus and Elisha Hospital in Haifa, Israel, said. “We also know that over the last 15 to 20 years, there’s been accumulating data that we actually miss adenomas. This is primarily because we still are using inadequate optics and visualization techniques with colonoscopes today. … We believe that FUSE is an advancement in colonoscopy technology.”
Among those who initially received TFV, 28 adenomas were found, with an additional 20 adenomas detected among 15 patients during subsequent FUSE colonoscopy (71.4% increase in found adenomas, 42% missed adenoma rate for TFV). Among those who first underwent FUSE, 59 adenomas and two cancers were detected, with an additional five adenomas observed during subsequent TFV colonoscopy in no unique patients (8.2% increase in found adenomas, 7.6% missed adenoma rate for FUSE) (P<.0001 for comparisons of found and missed adenoma rates).
Of the 20 adenomas missed via TFV, 18 were sessile, the majority were tubular, and 70% were located in the right colon, with only one adenoma larger than 10 mm. Eight of the 15 patients in whom additional adenomas were detected via FUSE received updated surveillance recommendations: From 5 to 10 years to 3 years in six cases, and from 10 years to within 5 to10 years in two cases. The five adenomas missed by FUSE were all sessile, tubular and small in size, and no changes in surveillance recommendations were made.
EndoChoice announced here that the FUSE system had received FDA 510(k) clearance, and indicated plans to incorporate the colonoscope into additional facilities worldwide this year in a press release.
Disclosure: The researchers report numerous financial disclosures.
For more information:
Gralnek IM. #9a: Comparing Traditional Forward-Viewing Colonoscopy with “Full Spectrum Endoscopy”: a Randomized, Multicenter Tandem Colonoscopy Study — the FUSE Study. Presented at: Digestive Disease Week 2013; May 18-21, Orlando, Fla.