Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial.

BACKGROUND: Artificial intelligence systems have been developed to improve polyp detection. We aimed to evaluate the effect of real-time computer-aided detection (CADe) on the adenoma detection rate (ADR) in routine colonoscopy. METHODS: This single-centre randomised controlled trial (COLO-GENIUS) was done at the Digestive Endoscopy Unit, Pôle Digestif Paris-Bercy, Clinique Paris-Bercy, Charenton-le-Pont, France. All consecutive individuals aged 18 years or older who were scheduled for a total colonoscopy and had an American Society of Anesthesiologists score of 1-3 were screened for inclusion. After the caecum was reached and the colonic preparation was appropriate, eligible participants were randomly assigned (1:1; computer-generated random numbers list) to either standard colonoscopy or CADe-assisted colonoscopy (GI Genius 2.0.2; Medtronic). Participants and cytopathologists were masked to study assignment, whereas endoscopists were not. The primary outcome was ADR, which was assessed in the modified intention-to-treat population (all randomly assigned participants except those with misplaced consent forms). Safety was analysed in all included patients. According to statistical calculations, 20 endoscopists from the Clinique Paris-Bercy had to include approximately 2100 participants with 1:1 randomisation. The trial is complete and registered with ClinicalTrials.gov, NCT04440865. FINDINGS: Between May 1, 2021, and May 1, 2022, 2592 participants were assessed for eligibility, of whom 2039 were randomly assigned to standard colonoscopy (n=1026) or CADe-assisted colonoscopy (n=1013). 14 participants in the standard group and ten participants in the CADe group were then excluded due to misplaced consent forms, leaving 2015 participants (979 [48·6%] men and 1036 [51·4%] women) in the modified intention-to-treat analysis. ADR was 33·7% (341 of 1012 colonoscopies) in the standard group and 37·5% (376 of 1003 colonoscopies) in the CADe group (estimated mean absolute difference 4·1 percentage points [95% CI 0·0-8·1]; p=0·051). One bleeding event without deglobulisation occurred in the CADe group after a large (>2 cm) polyp resection and resolved after a haemostasis clip was placed during a second colonoscopy. INTERPRETATION: Our findings support the benefits of CADe, even in a non-academic centre. Systematic use of CADe in routine colonoscopy should be considered. FUNDING: None.

Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial.

OBJECTIVE: Endocuff Vision (ECV) is the second generation of a device designed to improve polyp detection. The aim of this study was to evaluate its impact on adenoma detection rate (ADR) in routine colonoscopy. DESIGN: This cluster-randomised crossover trial compared Endocuff-assisted (ECV+) with standard (ECV-) colonoscopy. Two teams of 11 endoscopists each with prior ECV experience, balanced in terms of basal ADR, gender and case volume were compared. In randomised fashion, the teams started with ECV+ or ECV- and switched group after inclusion of half of the cases. The main outcome criterion was ADR difference between ECV+ and ECV-. Subgroup analysis was done for physicians with low and high ADR (< or ≥ 25%). RESULTS: During two periods of 20 and 21 weeks, respectively, the 22 endoscopists included 2058 patients (1032 ECV- vs 1026 ECV+, both groups being comparable). Overall ADR for both groups taken together was higher with ECV (39.2%) than without (29.4%; p<0.001) irrespective of the sequence of use (ECV+ or ECV- first), but mostly in adenomas <1 cm. In the physician subgroup analysis, only high detectors showed a significant ADR increase (from 31% to 41%, p<0.001), while the increase in the low detectors was not significant (from 24% to 30%, p=0.11). ECV had a positive impact in all colonic locations, except for the rectum. No ECV- related complication was reported. CONCLUSION: We observed a significant ADR difference of approximately 10% by the use of ECV. By subgroup analysis, this increase was significant only in physicians classified as high detectors. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03344055).