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DOI: 10.1055/s-0043-1765012
Clinical validation of a computer-aided detection model for colorectal polyp detection (CAD-ARTIPOD) trial using a second observer and real-time unblinding
Aims This trial aimed to validate a CADe system for colorectal polyp detection versus trained endoscopists in an endoscopy blinded set-up with real-time unblinding.
Methods The CAD-ARTIPOD trial is a prospective multicenter trial conducted in 9 European centers. CADe specifics were published earlier [1]. Sample size analysis for superiority required 2048 polyps assuming a difference in sensitivity of 2% with endoscopic diagnosis as gold standard. All endoscopists (ADR 20-50%) were blinded for the CADe output. A second observer classified in real time the CADe output in (1) true positive (detected/not detected by the endoscopist) (2) false negative or (3) clinically relevant or irrelevant false positive detection. If a polyp was only detected by CADe, the endoscopist was unblinded for confirmation of the finding. Histological assessment of endoscopically confirmed polyps was performed by two independent histopathologists.
Results A number of 2080 polyps were collected, 1549 were histologically confirmed polyps.
For the primary endpoint superiority was not reached between CADe and endoscopists (sensitivity (Sn) of 0.94 vs 0.96) (non-inferiority margin of 5%, p = 0.0216). False positive rate was 1.8/min. With histology as standard, CADe outperformed the endoscopists (Sn 0.96 versus 0.95 (p=0.03)) and showed an extra detection rate of 4.8% (Fig. [1]).
Conclusions This manufacturer independent CADe system used in an innovative and competitive study design demonstrated non-inferiority in comparison to endoscopists’ polyp detection. However, with histology as gold standard CADe outperformed endoscopists. Our study also shows that “watching over a shoulder” in itself leads to higher PDR and ADR
Publication History
Article published online:
14 April 2023
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- 1 Sinonquel P, Eelbode T, Hassan C. et al. Real-time unblinding for validation of a new CADe tool for colorectal polyp detection. Gut 2021; 70 (04) 641-643