Artificial intelligence and colonoscopy experience: lessons from two randomised trials

Alessandro Repici(Humanitas University), Marco Spadaccini(Humanitas University), Giulio Antonelli(Ospedale Regina Margherita), Loredana Correale(Humanitas University), Roberta Maselli(Humanitas University), P.A. Galtieri(Humanitas University), Gaia Pellegatta(Humanitas University), Antonio Capogreco(Humanitas University), Sebastian Manuel Milluzzo(Fondazione Poliambulanza Istituto Ospedaliero), Gianluca Lollo(Università della Svizzera italiana), Dhanai Di Paolo(Ospedale Valduce), Matteo Badalamenti(Humanitas University), E.C. Ferrara(Humanitas University), Alessandro Fugazza(Humanitas University), Silvia Carrara(Humanitas University), Andrea Anderloni(Humanitas University), Emanuele Rondonotti(Ospedale Valduce), Arnaldo Amato(Ospedale Valduce), Andrea De Gottardi(Università della Svizzera italiana), Cristiano Spada(Fondazione Poliambulanza Istituto Ospedaliero), Franco Radaelli(Ospedale Valduce), Victor Savevski(Humanitas University), Michael B. Wallace(Mayo Clinic in Florida), Prateek Sharma(University of Kansas), Thomas Rösch(Universität Hamburg), Cesare Hassan(Ospedale Regina Margherita)
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Abstract

BACKGROUND AND AIMS: Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). METHODS: In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. RESULTS: In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. CONCLUSIONS: In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR. TRIAL REGISTRATION NUMBER: NCT:04260321.


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