Hassan C, Rizkala T, Mori Y, Spadaccini M, Misawa M, Antonelli G, Rondonotti E, Dekker E, Houwen BBSL, Pech O, Baumer S, Li JW, von Renteln D, Haumesser C, Maselli R, Facciorusso A, Correale L, Menini M, Schilirò A, Khalaf K, Patel H, Radadiya DK, Bhandari P, Kudo SE, Sultan S, Vandvik PO, Sharma P, Rex DK, Foroutan F, and Repici A
Background: The resect-and-discard strategy allows endoscopists to replace post-polypectomy pathology with real-time prediction of polyp histology during colonoscopy (optical diagnosis). We aimed to investigate the benefits and harms of implementing computer-aided diagnosis (CADx) for polyp pathology into the resect-and-discard strategy., Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, and Scopus from database inception to June 5, 2024, without language restrictions, for diagnostic accuracy studies that assessed the performance of real-time CADx systems, compared with histology, for the optical diagnosis of diminutive polyps (≤5 mm) in the entire colon. We synthesised data for three strategies: CADx-alone, CADx-unassisted, and CADx-assisted; when the endoscopist was involved in the optical diagnosis, we synthesised data exclusively from diagnoses for which confidence in the prediction was reported as high. The primary outcomes were the proportion of polyps that would have avoided pathological assessment (ie, the proportion optically diagnosed with high confidence; main benefit) and the proportion of polyps incorrectly predicted due to false positives and false negatives (main harm), directly compared between CADx-assisted and CADx-unassisted strategies. We used DerSimonian and Laird's random-effects model to calculate all outcomes. We used Higgins I 2 to assess heterogeneity, the Grading of Recommendations, Assessment, Development, and Evaluation approach to rate certainty, and funnel plots and Egger's test to examine publication bias. This study is registered with PROSPERO, CRD42024508440., Findings: We found 1019 studies, of which 11 (7400 diminutive polyps, 3769 patients, and 185 endoscopists) were included in the final meta-analysis. Three studies (1817 patients and 4086 polyps [2148 neoplastic and 1938 non-neoplastic]) provided data to directly compare the primary outcome measures between the CADx-unassisted and CADx-assisted strategies. We found no significant difference between the CADx-assisted and CADx-unassisted strategies for the proportion of polyps that would have avoided pathological assessment (90% [88-93], 3653 [89·4%] of 4086 polyps diagnosed with high confidence vs 90% [95% CI 85-94], 3588 [87·8%] of 4086 polyps diagnosed with high confidence; risk ratio 1·01 [95% CI 0·99-1·04; I 2 =53·49%; low-certainty evidence; Egger's test p=0·18). The proportion of incorrectly predicted polyps was lower with the CADx-assisted strategy than with the CADx-unassisted strategy (12% [95% CI 7-17], 523 [14·3%] of 3653 polyps incorrectly predicted with a CADx-assisted strategy vs 13% [6-20], 582 [16·2%] of 3588 polyps incorrectly diagnosed with a CADx-unassisted strategy; risk ratio 0·88 [95% CI 0·79-0·98]; I 2 =0·00%; low-certainty evidence; Egger's test p=0·18)., Interpretation: CADx did not produce benefit nor harm for the resect-and-discard strategy, questioning its value in clinical practice. Improving the accuracy and explainability of CADx is desired., Funding: European Commission (Horizon Europe), the Japan Society of Promotion of Science, and Associazione Italiana per la Ricerca sul Cancro., Competing Interests: Declaration of interests CHas reports consultancy fees from Fujifilm and Medtronic. YM reports consultancy fees, speaking honoraria, and equipment loan from Olympus, and license fee for the co-developed artificial intelligence medical devices from Cybernet System (in the field of colonoscopy, one of which has been included in the analysis in this Article). AR reports consultancy fees from Fujifilm, Olympus, and Medtronic. DvR reports research grants from Fujifilm, Eberhard & Robert Bosch Elektronik (ERBE), and Boston Scientific; speaker fees from Fujifilm, ERBE, Boston Scientific, and Medtronic; support for attending meetings from Fujifilm and ERBE, and endoscopy device loan from Fujifilm and ERBE. ER reports speaking honoraria from Fujifilm; consultancy fees from Medtronic; and speaker fees from Fujifilm. OP reports speaker fees from Medtronic, Boston Scientific, AbbVie, Falk, Luvos, and Olympus. ED reports consulting fees from Olympus, Fujifilm, Ambu, InterVenn, Norgine, and Exact Science; speaker fees from Olympus, GI Supply, Norgine, IPSEN-Mayoly, and Fujifilm; and endoscopy device loan from Fujifilm. POV reports research grant from European Comission (Horizon Europe 101057099). PS reports research grants from ERBE, Fujifilm, Nippon Electric Company, and Sebela; and consulting fees from Olympus, Boston Scientific, Salix Pharmaceuticals, Cipla, Medtronic, Takeda, Samsung Bioepis, and CDx. DKR reports research grants from Olympus, Sebela Pharmaceuticals, and ERBE; consulting fees from Olympus, Sebela Pharmaceuticals, Boston Scientific, and Laborie Medical; speaker fees from Boston Scientific, Laborie Medical, and Medtronic; and ownership of stock in Satisfai Health. PB reports research grants from NEC-Europe, Boston Scientific, and 3-D matrix and consulting fees from Fujifilm. GA reports research grants from the European Society of Gastrointestinal Endoscopy, consulting fees from Medtronic and Cosmo IMD, and speaker fees from Medtronic. JWL reports speaker fees from Olympus and Fujifilm. MMe reports license fee for the co-developed artificial intelligence medical devices from Cybernet System (in the field of colonoscopy, one of which has been included in the analysis in this Article) and consulting fees and speaker fees from Olympus. S-eK reports license fees for the co-developed artificial intelligence medical devices from Cybernet System (in the field of colonoscopy, one of which has been included in the analysis in this Article) and speaker fees from Olympus. RM reports research grants from ERBE, Fujifilm, Olympus, Pentax, and Boston Scientific. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)