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Effect of Combination of a Mucosal Exposure Device and Computer-Aided Detection in Diagnostic, Screening, and
Michiel H J Maas1, Milou L M van Riswijk1, Timo Rath2
1Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.
Introduction:
Mucosal exposure devices (MEDs) and computer-aided detection (CADe) systems may both improve adenoma detection through distinct mechanisms: expanding mucosal visualization and highlighting lesions, respectively. This study investigated the efficacy of combining CADe-assisted colonoscopy with a MED compared with CADe-assisted colonoscopy alone.
Methods:
This international, multicenter, prospective, nonrandomized, single-arm study (NTC05220345) was conducted at 3 centers that also participated in the previous DISCOVERY II randomized controlled trial, comparing CADe-assisted with conventional colonoscopy. Eligible participants were patients referred for diagnostic, nonfecal immunochemical test screening, or surveillance colonoscopy and underwent CADe-assisted colonoscopy (DISCOVERY, PENTAX Medical) with a MED using an integrated inflatable balloon (G-EYE, SMART Medical Systems). The primary outcome was adenoma detection rate (ADR); secondary outcomes included sessile serrated lesion detection rate and withdrawal time without interventions. Outcomes were compared with historical controls of the CADe-arm of the DISCOVERY II study.
Results:
Of 196 enrolled participants, 182 were included in the final analysis and compared with 250 participants from the historical CADe-arm. ADR was 47.3% in the CADe + MED-group vs 38.4% in the CADe-group ( P = .066; absolute difference: 8.9%, 95% confidence interval: 0.6-18.3). Mixed-effects logistic regression model adjusting for clustering and confounders calculated an odds ratio of 1.16 (95% confidence interval: 0.74-1.81). Median withdrawal time was slightly longer with CADe + MED compared with CADe-only (10.0 vs 9.2 minutes, P = 0.004), whereas sessile serrated lesion detection rate was not significantly different (12.6% vs 18.4%, P = 0.11).
Discussion:
In this study using historical controls, CADe-assisted colonoscopy combined with a MED did not significantly increase ADR compared with CADe alone, suggesting limited synergistic benefit.
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