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Endocuff detects more adenomas per patient, but fails to increase ADR
Endocuff-assisted colonoscopy increased the number of adenomas detected per patient — particularly diminutive and flat adenomas — compared with traditional colonoscopy, but did not increase the number of patients in whom at least one adenoma was detected, according to the results of a randomized controlled trial.
Endocuff (Arc Medical Design) is an endoscopic cap designed to improve adenoma detection and control of the scope tip. It is a 2 cm long flexible cap with two rings of plastic, hinged “hairs” that may straighten mucosal folds during scope withdrawal, investigators wrote.
Previous studies have shown the Endocuff improved adenoma detection, and the FDA recently granted 510(k) clearance of claim's that the device improves adenoma detection rates. However, larger studies are needed to confirm improvements to the mean number of adenomas detected per colonoscopy in addition to the adenoma detection rate, investigators wrote.
Therefore, from August 2013 to October 2014, they randomly assigned 1,063 colonoscopy patients (52% men; median age, 65 years) to undergo Endocuff-assisted colonoscopy (n = 530) or conventional colonoscopy (n = 533) in five hospitals in the Netherlands. Experienced colonoscopists trained to use Endocuff performed all the procedures.
Overall, Endocuff-assisted colonoscopy detected 722 adenomas compared with 621 detected with conventional colonoscopy. This corresponded to a mean of 1.36 vs. 1.17 adenomas detected per patient, for an average gain of 0.19 adenomas per patient with Endocuff, which was not a statistically significant increase. However, the increase reached significance in the per-protocol analysis of patients in whom the allocated procedure was successfully completed (1.44 vs. 1.19; P = .02).
Further, colonoscopists detected at least one adenoma in 52% of both groups, and at least one advanced adenoma in 21% of the Endocuff group and 22% conventional group.
Endocuff-assisted procedures “specifically increased the detection of diminutive adenomas, flat adenomas and adenomas in the descending colon,” the researchers noted.
In 4.2% of the Endocuff-assisted procedures, colonoscopists removed the device because intubation beyond the sigmoid was not possible, and the adjusted cecal intubation rate was therefore significantly lower in the Endocuff group compared with the conventional colonoscopy group (94% vs. 99%; P < .001). However, conventional colonoscopy was successful in most of these patients after removing the device, so adjusted cecal intubation rates were statistically comparable in the intention-to-treat analyses (98% vs. 99%).
Endocuff-assisted procedures also had significantly shorter cecal intubation times (7 vs. 8.3 minutes; P < .001) and net withdrawal times in negative colonoscopies (median 7 vs. 8 minutes; P = .02). Only a few minor complications occurred in each group.
The investigators concluded that while Endocuff increased the yield of colonoscopy, routine use of the device did not increase the number of patients in whom at least one adenoma is detected. Future studies are needed to further evaluate the link between the mean number of adenomas detected per patient and the occurrence of interval carcinomas, they added. – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.