Polyp Detection with Colonoscopy Assisted by the GI Genius Artificial Intelligence Endoscopy Module Compared with Standard Colonoscopy in Routine Colonoscopy Practice (COLO-DETECT): a Multicentre, Open-Label, Parallel-Arm, Pragmatic Randomised Controlled Trial

Background Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice. Methods We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged >= 18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete. Findings Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [557%] male, 900 [443%] female; mean age 624 years [SD 108]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (606%) participants were undergoing screening and 801 (394%) had symptomatic indications. Mean adenomas per procedure was 156 (SD 282; n=1001 participants with available data) in the CADeassisted colonoscopy group versus 121 (191; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 036 (95% CI 014-057; adjusted incidence rate ratio 130 [95% CI 115-147], p<00001). Adenomas were detected in 555 (566%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (484%) of 986 in the standard colonoscopy group, representing a proportion difference of 83% (95% CI 39-127; adjusted odds ratio 147 [95% CI 121-178], p<00001). Numbers of adverse events were similar between the CADe-assisted colonoscopy and standard colonoscopy groups (adverse events: 25 vs 19; serious adverse events: four vs six), and no adverse events in the CADe-assisted colonoscopy group were deemed to be related to GI Genius use on independent review. Interpretation Results of the COLO-DETECT trial support the use of GI Genius to increase detection of premalignant colorectal polyps in routine colonoscopy practice.