Higher Adenoma Detection Rates with Endocuff-Assisted Colonoscopy – A Randomized Controlled Multicenter Trial

<div><p>Objectives</p><p>The Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).</p><p>Methods</p><p>This randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany. Participants: 500 patients (235 males, median age 64[IQR 54–73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).</p><p>Results</p><p>The ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29–41%] vs. 20.7%[95%CI 15–26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01–1.05), male sex (OR 1.74; 95%CI 1.10–2.73), withdrawal time (OR 1.16; 95%CI 1.05–1.30), procedure time (OR 1.07; 95%CI 1.04–1.10), colon cleanliness (OR 0.60; 95%CI 0.39–0.94) and use of Endocuff (OR 2.09; 95%CI 1.34–3.27) were independent predictors of adenoma detection rates.</p><p>Conclusions</p><p>EC increases the adenoma detection rate by 14.7%(95%CI 6.9–22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/results?term=NCT02034929" target="_blank">NCT02034929</a>.</p></div

Main outcomes of endoscopic procedures.

<p>IQR: interquartile range.</p><p>Main outcomes of endoscopic procedures.</p

Polyp and adenoma detection analysis.

<p>*only patients considered in whom at least one adenoma or polyp, respectively were detected.</p>#<p>3 polyps (EC) and two polyps (SC) not retrieved endoscopically.</p><p>Polyp and adenoma detection analysis.</p

Enrollment flow chart.

<p>Enrollment flow chart.</p

Forest plot showing the results of multivariate regression analysis for adenoma detection.

<p>The x-axis represents the Odds ratio on a log scale with the reference line (dashed), Odds ratios (diamond) and 95% CI (whiskers).</p

Baseline demographic and clinical characteristics.

<p>ASS = acetylsalicylate; IQR = interquartile range.</p><p>Baseline demographic and clinical characteristics.</p