The Efficacy of Real-Time Computer-Aided Detection of Colonic Neoplasia In Community Practice: A Pragmatic Randomized Controlled Trial.

Background The use of computer-aided detection (CADe) has increased the adenoma detection rates (ADR) during colorectal cancer (CRC) screening/surveillance in randomized controlled trials (RCT) but has not shown benefit in real-world implementation studies. We performed a single-center pragmatic RCT to evaluate the impact of real-time CADe on ADR in colonoscopy performed by community gastroenterologists. Methods We enrolled 1100 patients undergoing colonoscopy for CRC screening, surveillance, positive fecal-immunohistochemical tests, and diagnostic indications at one community-based center from 09/2022 to 03/2023. Patients were randomly assigned (1:1) to traditional-colonoscopy or real-time CADe Blinded pathologists analyzed histopathologic findings. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy (APC), sessile-serrated lesion detection rate (SSLDR), and non-neoplastic resection rate. Results The median age was 55.5 (IQR 50-62), 61% were female, 72.7% were Hispanic ethnicity, and 9.1% had inadequate bowel preparation. The ADR for the CADe group was significantly higher than the traditional-colonoscopy group (42.5% vs. 34.4%, p=0.005). The mean APC was significantly higher in the CADe group compared to the traditional-colonoscopy group (0.89±1.46 vs. 0.60±1.12, p<0.001). The improvement in adenoma detection was driven by increased detection of <5 mm adenomas. CADe had a higher SSLDR than traditional-colonoscopy (4.7% vs. 2.0%, p=0.01) The improvement in ADR with CADe was significantly higher in the first half of the study (47.2% vs. 33.7%, p=0.002) compared to the second half (38.7% vs. 34.9%, p=0.33). Conclusions In a single-center pragmatic randomized controlled trial, real-time CADe modestly improved ADR and APC in average-detector community endoscopists. (ClinicalTrials.gov number, NCT05963724).