Artificial intelligence for diagnosing neoplasia on digital cholangioscopy: development and multicenter validation of a convolutional neural network model.

Background: We aimed to develop a convolutional neural network (CNN) model for detecting neoplastic lesions during real-time digital single-operator cholangioscopy (DSOC) and to clinically validate the model through comparisons with DSOC expert and nonexpert endoscopists.
Methods: In this two-stage study, we first developed and validated CNN1. Then, we performed a multicenter diagnostic trial to compare four DSOC experts and nonexperts against an improved model (CNN2). Lesions were classified into neoplastic and non-neoplastic in accordance with Carlos Robles-Medranda (CRM) and Mendoza disaggregated criteria. The final diagnosis of neoplasia was based on histopathology and 12-month follow-up outcomes.
Results: In stage I, CNN2 achieved a mean average precision of 0.88, an intersection over the union value of 83.24 %, and a total loss of 0.0975. For clinical validation, a total of 170 videos from newly included patients were analyzed with the CNN2. Half of cases (50 %) had neoplastic lesions. This model achieved significant accuracy values for neoplastic diagnosis, with a 90.5 % sensitivity, 68.2 % specificity, and 74.0 % and 87.8 % positive and negative predictive values, respectively. The CNN2 model outperformed nonexpert #2 (area under the receiver operating characteristic curve [AUC]-CRM 0.657 vs. AUC-CNN2 0.794, P  < 0.05; AUC-Mendoza 0.582 vs. AUC-CNN2 0.794, P  < 0.05), nonexpert #4 (AUC-CRM 0.683 vs. AUC-CNN2 0.791, P  < 0.05), and expert #4 (AUC-CRM 0.755 vs. AUC-CNN2 0.848, P  < 0.05; AUC-Mendoza 0.753 vs. AUC-CNN2 0.848, P  < 0.05).
Conclusions: The proposed CNN model distinguished neoplastic bile duct lesions with good accuracy and outperformed two nonexpert and one expert endoscopist.
Competing Interests: C. Robles-Medranda is a key opinion leader and consultant for Pentax Medical, Steris, Micro-tech, G-Tech Medical Supply, CREO Medical, and mdconsgroup, and is a board member and consultant for EndoSound. M. Kahaleh is a consultant for Boston Scientific, Interscope Med, and Abbvie; a grant recipient from Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, Olympus Medical, and Ninepoint Medical; and the chief executive officer and founder of Innovative Digestive Health Education & Research Inc. A. Tyberg is a consultant for Ninepoint Medical, EndoGastric Solutions, and Obalon Therapeutics. I. Raijman is a speaker for Boston Scientific, ConMed, Medtronic, and GI Supplies; an advisory board member for Microtech; and a co-owner of EndoRx. R. Kunda is a consultant for Olympus, Boston Scientific, Omega Medical Imaging, M.I. Tech, Tigen Pharma, and Ambu. J. Baquerizo-Burgos, J. Alcivar-Vasquez, M. Puga-Tejada, M. Egas-Izquierdo, M. Arevalo-Mora, J.C. Mendez, A. Sarkar, H. Shahid, R. del Valle-Zavala, J. Rodriguez, R.C. Merfea, J. Barreto-Perez, G. Saldaña-Pazmiño, D. Calle-Loffredo, H. Alvarado, and H.P. Lukashok declare that they have no conflict of interest.
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