Rex DK, Bhavsar-Burke I, Buckles D, Burton J, Cartee A, Comar K, Edwards A, Fennimore B, Fischer M, Gerich M, Gilmore A, Hamdeh S, Hoffman J, Ibach M, Jackson M, James-Stevenson T, Kaltenbach T, Kaplan J, Kapur S, Kohm D, Kriss M, Kundumadam S, Kyanam Kabir Baig KR, Menard-Katcher P, Kraft C, Langworthy J, Misra B, Molloy E, Munoz JC, Norvell J, Nowak T, Obaitan I, Patel S, Patel M, Peter S, Reid BM, Rogers N, Ross J, Ryan J, Sagi S, Saito A, Samo S, Sarkis F, Scott FI, Siwiec R, Sullivan S, Wieland A, Zhang J, Repici A, Hassan C, Byrne MF, and Rastogi A
Background: Real-time prediction of histologic features of small colorectal polyps may prevent resection and/or pathologic evaluation and therefore decrease colonoscopy costs. Previous studies showed that computer-aided diagnosis (CADx) was highly accurate, though it did not outperform expert endoscopists., Objective: To assess the diagnostic performance of histologic predictions by general endoscopists before and after assistance from CADx in a real-life setting., Design: Prospective, multicenter, single-group study. (ClinicalTrials.gov: NCT04437615)., Setting: 6 centers across the United States., Participants: 1252 consecutive patients undergoing colonoscopy and 49 general endoscopists with variable experience in real-time prediction of polyp histologic features., Intervention: Real-time use of CADx during routine colonoscopy., Measurements: The primary end points were the sensitivity and specificity of CADx-unassisted and CADx-assisted histologic predictions for adenomas measuring 5 mm or less. For clinical purposes, additional estimates according to location and confidence level were provided., Results: The CADx device made a diagnosis for 2695 polyps measuring 5 mm or less (96%) in 1252 patients. There was no difference in sensitivity between the unassisted and assisted groups (90.7% vs. 90.8%; P = 0.52). Specificity was higher in the CADx-assisted group (59.5% vs. 64.7%; P < 0.001). Among all 2695 polyps measuring 5 mm or less, 88.2% and 86.1% ( P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be resected and discarded without pathologic evaluation. Among 743 rectosigmoid polyps measuring 5 mm or less, 49.5% and 47.9% ( P < 0.001) in the CADx-assisted and unassisted groups, respectively, could be left in situ without resection., Limitation: Decision making based on CADx might differ outside a clinical trial., Conclusion: CADx assistance did not result in increased sensitivity of optical diagnosis. Despite a slight increase, the specificity of CADx-assisted diagnosis remained suboptimal., Primary Funding Source: Olympus America Corporation served as the clinical study sponsor., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M24-0086.