Effect of combination of a mucosal exposure device and computer-aided detection in diagnostic, screening and surveillance colonoscopy: an international, multicenter study

Abstract

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 to CADe-assisted colonoscopy alone. Methods: This international, multicenter, prospective, non-randomized, single-arm study (NTC05220345) was conducted at three centers that also participated in the previous DISCOVERY II randomized controlled trial, comparing CADe-assisted with conventional colonoscopy. Patients referred for diagnostic, non-fecal immunochemical test screening, or surveillance colonoscopy and underwent CADe-assisted colonoscopy (DISCOVERY™, PENTAX Medical) with a MED using an integrated inflatable balloon (G-EYE™, PENTAX Medical). The primary outcome was adenoma detection rate (ADR); secondary outcomes included sessile serrated lesion detection rate (SSLDR) and withdrawal time without interventions. Outcomes were compared to 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% CI: –0.6-18.3). Mixed-effects logistic regression model adjusting for clustering and confounders calculated an odds ratio of 1.16 (95% CI: 0.74-1.81). Median withdrawal time was slightly longer with CADe + MED compared to CADe-only (10.0 vs. 9.2 minutes, p=.004), while SSLDR was not significantly different (12.6% vs. 18.4%, p=.11). Conclusions: In this study using historical controls, CADe-assisted colonoscopy combined with a MED did not significantly increase ADR compared to CADe alone, suggesting limited synergistic benefit.

Affiliated Institutions

• Universitätsklinikum Erlangen DE
• Istituti di Ricovero e Cura a Carattere Scientifico IT
• Fondazione Poliambulanza Istituto Ospedaliero IT
• Università Cattolica del Sacro Cuore IT
• Erasmus MC NL
• Radboud University Nijmegen NL

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