Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial

BACKGROUND & AIMS: Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neo-plasias during colonoscopy in a multicenter randomized trial. METHODS: Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial in-dications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combina-tions of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histo-logically proven adenomas), and withdrawal time. RESULTS: From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was signifi- cantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00-1.26; P = .04). Ade-nomas detected per colonoscopy were significantly higher in the ECV group (mean & PLUSMN; SD, 0.94 & PLUSMN; 0.54) than in the control group (0.74 & PLUSMN; 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04-1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant differ-ence between groups in mean & PLUSMN; SD withdrawal time (9.01 & PLUSMN; 2.48 seconds for the ECV group vs 8.96 & PLUSMN; 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk,0.89; 95% CI, 0.69- 1.14; P = .38). CONCLUSIONS: The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing with-drawal time compared with CADe alone. ClinicalTrials.gov, Number: NCT04676308.

Automated summary

In this multicenter randomized trial, the combination of CADe and Endocuff during colonoscopy was found to increase adenoma detection rate and the number of adenomas detected per colonoscopy compared to CADe alone, without increasing withdrawal time. The integrity of colonoscopy was not compromised with this combination.