PolyDeep Advance 1: Clinical Validation of a Computer-Aided Detection System for Colorectal Polyp Detection with a Second Observer Design.

PolyDeep is a computer-aided detection and characterization system that has demonstrated a high diagnostic yield for in vitro detection of colorectal polyps. Our objective is to compare the diagnostic performance of expert endoscopists and PolyDeep for colorectal polyp detection. PolyDeep Advance 1 (NCT05514301) is an unicentric diagnostic test study with a second observer design. Endoscopists performed colonoscopy blinded to PolyDeep's detection results. The main endpoint was the sensitivity for colorectal polyp (adenoma, serrated or hyperplastic lesion) detection. The secondary endpoints were the diagnostic performance for diminutive lesions (≤5 mm), neoplasia (adenoma, serrated lesion) and adenoma detection. We included 205 patients (55.1% male, 63.0 ± 6.2 years of age) referred to colonoscopy (positive faecal immunochemical occult blood test = 60.5%, surveillance colonoscopy = 39.5%). We excluded eight patients due to incomplete colonoscopy. Endoscopists detected 384 lesions, of which 39 were not detected by PolyDeep. In contrast, PolyDeep predicted 410 possible additional lesions, 26 of these predictions confirmed by endoscopists as lesions, resulting in a potential 6.8% detection increase with respect to the 384 lesions detected by the endoscopists. In total, 410 lesions were detected, 20 were not retrieved, five were colorectal adenocarcinoma, 343 were colorectal polyps (231 adenomas, 39 serrated and 73 hyperplastic polyps), 42 were normal mucosa and 289 were ≤5 mm. We did not find statistically significant differences between endoscopists and PolyDeep for colorectal polyp detection (Sensitivity = 94.2%, 91.5%, = 0.2; Specificity = 9.5%, 14.3%, = 0.7), diminutive lesions (Sensitivity = 92.3%, 89.5%, = 0.4; Specificity = 9.8%, 14.6%, = 0.7), neoplasia (Sensitivity = 95.2%, 92.9%, = 0.3; Specificity = 9.6%, 13.9%, = 0.4) and adenoma detection (Sensitivity = 94.4%, 92.6%, = 0.5; Specificity = 7.2%, 11.8%, = 0.2). Expert endoscopists and PolyDeep have similar diagnostic performance for colorectal polyp detection.