New Colonoscope Offers 330-Degree View of the Colon

Caroline Helwick

May 19, 2013

ORLANDO, Florida — A new colonoscope that provides a sweeping view of the colon could significantly improve the ability of the examination to detect adenomas, according to investigators evaluating the Full Spectrum Endoscopy (FUSE) colonoscope.

"As compared to traditional forward-viewing colonoscopy, FUSE found significantly more adenomas, had a significantly lower adenoma miss rate, and impacted colonoscopy surveillance recommendations," said Ian Gralnek, MD, from the Technion-Israel Institute of Technology and the Elisha Hospital in Haifa.

"Our results are very compelling," Dr. Gralnek said here at Digestive Disease Week (DDW) 2013. "We believe that FUSE is an advance in colonoscopy technology."

Dr. Gralnek presented the results of the comparison as a late-breaker at the Presidential Plenary Session of the American Gastroenterological Association (AGA) and the American Society for Gastrointestinal Endoscopy (ASGE).

Kenneth McQuaid, MD, from the University of California, San Francisco, Program Chair for the ASGE, called the technology, and the trial results, some of the most exciting news at DDW.

 
If the FUSE technology is confirmed by other studies, it promises to be a major breakthrough in colonoscopy. Dr. Kenneth McQuaid
 

"If the FUSE technology is confirmed by other studies, it promises to be a major breakthrough in colonoscopy," Dr. McQuaid told Medscape Medical News.

Developed by EndoChoice, the FUSE colonoscope maintains the identical technical features of the standard colonoscope but allows the endoscopist to view 330 degrees, compared with the 170-degree viewing angle of the traditional scope. "It looks and feels just like the ones we are using today," Dr. Gralnek noted.

With traditional colonoscopy, up to 31% of adenomas can be missed, primarily as a result of inadequate visualization of folds and flexures in the proximal colon. There is a need for improvements in colonoscope technology to expand visualization capabilities, he said.

The randomized, multicenter study, conducted between January 2012 and March 2013, followed a tandem colonoscopy design in which same-day, back-to-back colonoscopies using the approaches were performed by the same endoscopist.

Researchers conducted the final analysis on 185 patients, whose indications for colonoscopy included screening (55.7%), polyp surveillance (19.5%), and diagnostic evaluation (24.8%).

Among the cohort of 88 patients randomly assigned to receive traditional colonoscopy as their initial colonoscopy, followed by FUSE, 28 adenomas and cancers were detected on first pass, and an additional 20 were detected on second pass under FUSE visualization.

This amounted to a 71.4% increase in the number of adenomas found with FUSE, Dr. Galnek reported.

In contrast, among the 97 patients randomly assigned to receive FUSE first, followed by traditional colonoscopy, 61 adenomas and cancers were found, with only 5 additional lesions detected on the second pass, for an 8.2% increase in adenomas found using the conventional approach, he said. The difference in this comparison was highly significant (P < .0001), he noted.

Significant differences were also observed in missed adenomas and false-negative rates; adenoma detection rates per colonoscope type at first colonoscopy were numerically but not significantly improved.

Table. Colonoscopy Outcomes

Parameter Traditional Colonoscopy (%) Full Spectrum Endoscopy (%) P-Value
Additional adenomas detected (per lesion) 8.2 71.4 <.0001
Adenomas missed (per lesion) 41.7 7.6 <.0001
False-negative colonoscopies (per patient) 5.7 0
Adenoma detection rate per colonoscope type at 1st colonoscopy 27.3 33.0 =.4000

 

The vast majority of the 20 adenomas missed by traditional colonoscopy were sessile lesions in the right colon, primarily tubular adenomas measuring 1 to 5 mm. All of the 5 adenomas missed by FUSE were sessile, tubular subtype, measuring 1 to 5 mm; 2 were located in the right colon, and 3 in the left.

"The findings have implications for surveillance," Dr. Galnek pointed out. Of the 15 patients harboring these 20 missed adenomas, FUSE changed the colonoscopy surveillance schedule and lessened the interval for follow-up in 53.3%.

"The data we heard today suggest that it achieves higher adenoma detection rates, and we know that high adenoma detection rates correlate with a reduction in subsequent interval cancers," Dr. McQuaid said. "While most of the missed lesions were diminutive polyps, the study also showed that the approach translated into changing the recommended surveillance intervals in some patients. This ties together — the more adenomas we pick up, the fewer interval cancers we will find," he pointed out.

Dr. McQuaid said he would be interested in considering it for his service, "but we will have to look at cost, which will be a big factor."

Dr. Gralnek reported serving on advisory committees or review panels for Given Imaging and Motus GI and having consulted for Given Imaging, PeerMedical, and Astra-Zeneca. Dr. McQuaid reports no relevant financial relationships.

Digestive Disease Week (DDW) 2013. Abstract 9a. Presented May 18, 2013.

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