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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., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: Currently, there is insufficient data about the accuracy in the diagnosing of pancreatic cystic lesions (PCLs), especially with novel endoscopic techniques such as with direct intracystic micro-forceps biopsy (mFB) and needle-based confocal laser-endomicroscopy (nCLE)., Aim: To compare the accuracy of endoscopic ultrasound (EUS) and associated techniques for the detection of potentially malignant PCLs: EUS-guided fine needle aspiration (EUS-FNA), contrast-enhanced EUS (CE-EUS), EUS-guided fiberoptic probe cystoscopy (cystoscopy), mFB, and nCLE., Methods: This was a single-center, retrospective study. We identified patients who had undergone EUS, with or without additional diagnostic techniques, and had been diagnosed with PCLs. We determined agreement among malignancy after 24-mo follow-up findings with detection of potentially malignant PCLs via the EUS-guided techniques and/or EUS-guided biopsy when available (EUS malignancy detection)., Results: A total of 129 patients were included, with EUS performed alone in 47/129. In 82/129 patients, EUS procedures were performed with additional EUS-FNA (21/82), CE-EUS (20/82), cystoscopy (27/82), mFB (36/82), nCLE (44/82). Agreement between EUS malignancy detection and the 24-mo follow-up findings was higher when associated with additional diagnostic techniques than EUS alone [62/82 (75.6%) vs 8/47 (17%); OR 4.35, 95%CI: 2.70-7.37; P < 0.001]. The highest malignancy detection accuracy was reached when nCLE and direct intracystic mFB were both performed, with a sensitivity, specificity, positive predictive value, negative predictive value and observed agreement of 100%, 89.4%, 77.8%, 100% and 92.3%, respectively ( P < 0.001 compared with EUS-alone)., Conclusion: The combined use of EUS-guided mFB and nCLE improves detection of potentially malignant PCLs compared with EUS-alone, EUS-FNA, CE-EUS or cystoscopy., Competing Interests: Conflict-of-interest statement: Robles-Medranda C reports other from Pentax Medical, other from Boston Scientific, other from Steris, other from Medtronic, other from Motus, other from Micro-tech, other from G-Tech Medical Supply, other from CREO Medical, other from Mdconsgroup, outside the submitted work; The other authors declare no conflicts of interest., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)