{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T08:42:26Z","timestamp":1785400946301,"version":"3.56.0"},"reference-count":32,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:00:00Z","timestamp":1785024000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["62076194"],"award-info":[{"award-number":["62076194"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["62573342"],"award-info":[{"award-number":["62573342"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"award":["62076194"],"award-info":[{"award-number":["62076194"]}],"id":[{"id":"https:\/\/ror.org\/01h0zpd94","id-type":"ROR","asserted-by":"publisher"}]},{"award":["62573342"],"award-info":[{"award-number":["62573342"]}],"id":[{"id":"https:\/\/ror.org\/01h0zpd94","id-type":"ROR","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015401","name":"Key Research and Development Program of Shaanxi","doi-asserted-by":"publisher","award":["2025-SF-YBXM-386"],"award-info":[{"award-number":["2025-SF-YBXM-386"]}],"id":[{"id":"10.13039\/501100015401","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015401","name":"Key Research and Development Program of Shaanxi","doi-asserted-by":"publisher","award":["2022-SF-606"],"award-info":[{"award-number":["2022-SF-606"]}],"id":[{"id":"10.13039\/501100015401","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100015401","name":"Key Research and Development Program of Shaanxi","doi-asserted-by":"publisher","award":["2020SF-070"],"award-info":[{"award-number":["2020SF-070"]}],"id":[{"id":"10.13039\/501100015401","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Malignant biliary stricture (MBS) remains difficult to diagnose accurately despite digital single-operator cholangioscopy (DSOC). We developed a deep learning (DL)-based computer-aided detection (CADe) and diagnosis (CADx) system for DSOC-based MBS assessment. Methods: This retrospective multicenter study included 149 patients from one center for model development and internal validation and 25 patients from two independent centers for external evaluation. CADe used a You Only Look Once version 11 (YOLOv11) architecture to localize irregular mucosa, abnormal vasculature, and nodular protrusions defined by the Carlos Robles-Medranda and Mendoza criteria. CADx used a Residual Network-18 classifier with gradient-weighted class activation mapping for interpretability. Results: CADe achieved a mean average precision at 50% intersection-over-union of 91.2%, with a precision of 92.0% and recall of 87.0%. CADx achieved a frame-level area under the receiver operating characteristic curve (AUC) of 0.960 in internal validation and 0.843 in external validation. External frame-level sensitivity was 52.0% and specificity was 95.2%. For the patient-level external endpoint, sensitivity was 85.7%, specificity was 94.4%, accuracy was 92.0%, and AUC was 0.881. Conclusions: The two-stage system combines localization of predefined cholangioscopic features with interpretable diagnostic classification. The small external cohort and marked reduction in frame-level sensitivity preclude firm conclusions regarding generalizability; prospective multicenter and live-procedure evaluation is required.<\/jats:p>","DOI":"10.3390\/cancers18152410","type":"journal-article","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T05:49:27Z","timestamp":1785131367000},"page":"2410","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Deep Learning-Based Computer-Aided Detection and Diagnosis System for Malignant Biliary Stricture (With Video)"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-4715-5364","authenticated-orcid":false,"given":"Qingyu","family":"Tang","sequence":"first","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanping","family":"Zhou","sequence":"additional","affiliation":[{"name":"National Key Laboratory of Human-Machine Hybrid Augmented Intelligence, National Engineering Research Center for Visual Information and Applications, Institute of Artificial Intelligence and Robotics, Xi\u2019an Jiaotong University, Xi\u2019an 710049, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zizhan","family":"Tang","sequence":"additional","affiliation":[{"name":"USC Viterbi School of Engineering, University of Southern California, Los Angeles, CA 90089, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kangpeng","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zejian","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510120, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9301-0181","authenticated-orcid":false,"given":"Lei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510120, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dapeng","family":"Bian","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, Peking University First Hospital, Beijing 100034, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiushi","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, Peking University First Hospital, Beijing 100034, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qi","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Tao","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6636-6396","authenticated-orcid":false,"given":"Le","family":"Wang","sequence":"additional","affiliation":[{"name":"National Key Laboratory of Human-Machine Hybrid Augmented Intelligence, National Engineering Research Center for Visual Information and Applications, Institute of Artificial Intelligence and Robotics, Xi\u2019an Jiaotong University, Xi\u2019an 710049, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhimin","family":"Geng","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi\u2019an Jiaotong University, Xi\u2019an 710061, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"458","DOI":"10.1111\/j.1572-0241.2007.01645.x","article-title":"Management of Hilar Biliary Strictures","volume":"103","author":"Larghi","year":"2008","journal-title":"Am. J. Gastroenterol."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"European Association for the Study of the Liver (2025). EASL Clinical Practice Guidelines on the Management of Extrahepatic Cholangiocarcinoma. J. Hepatol., 83, 211\u2013238.","DOI":"10.1016\/j.jhep.2025.03.007"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1016\/j.gie.2014.09.017","article-title":"Comparative Effectiveness of Biliary Brush Cytology and Intraductal Biopsy for Detection of Malignant Biliary Strictures: A Systematic Review and Meta-Analysis","volume":"81","author":"Navaneethan","year":"2015","journal-title":"Gastrointest. Endosc."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1055\/a-0607-2534","article-title":"Reliability and Accuracy of a Novel Classification System Using Peroral Cholangioscopy for the Diagnosis of Bile Duct Lesions","volume":"50","author":"Valero","year":"2018","journal-title":"Endoscopy"},{"key":"ref_5","first-page":"33","article-title":"Diagnosis and Treatment of Biliary Malignancies: Biopsy, Cytology, Cholangioscopy and Stenting","volume":"5","author":"Chandrasekar","year":"2021","journal-title":"Mini-Invasive Surg."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"630","DOI":"10.1067\/mge.2000.108667","article-title":"Cholangioscopic Findings in Bile Duct Tumors","volume":"52","author":"Seo","year":"2000","journal-title":"Gastrointest. Endosc."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Wen, L.-J., Chen, J.-H., Xu, H.-J., Yu, Q., and Liu, K. (2020). Efficacy and Safety of Digital Single-Operator Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures by Targeted Biopsies: A Systematic Review and Meta-Analysis. Diagnostics, 10.","DOI":"10.3390\/diagnostics10090666"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1016\/j.gie.2014.12.021","article-title":"Is Single-Operator Peroral Cholangioscopy a Useful Tool for the Diagnosis of Indeterminate Biliary Lesion? A Systematic Review and Meta-Analysis","volume":"82","author":"Sun","year":"2015","journal-title":"Gastrointest. Endosc."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1002\/jhbp.1247","article-title":"Prospective Registration Study of Diagnostic Yield and Sample Size in Forceps Biopsy Using a Novel Device under Digital Cholangioscopy Guidance with Macroscopic On-Site Evaluation","volume":"30","author":"Ogura","year":"2023","journal-title":"J. Hepatobiliary Pancreat. Sci."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"2221","DOI":"10.1016\/j.cgh.2024.02.021","article-title":"The Efficacy of Real-Time Computer-Aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial","volume":"22","author":"Thiruvengadam","year":"2024","journal-title":"Clin. Gastroenterol. Hepatol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1038\/s41746-025-01652-9","article-title":"Multimodal GPT Model for Assisting Thyroid Nodule Diagnosis and Management","volume":"8","author":"Yao","year":"2025","journal-title":"npj Digit. Med."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"830","DOI":"10.1016\/j.gie.2024.09.001","article-title":"Multimodal Convolutional Neural Network-Based Algorithm for Real-Time Detection and Differentiation of Malignant and Inflammatory Biliary Strictures in Cholangioscopy: A Proof-of-Concept Study (with Video)","volume":"101","author":"Ziegler","year":"2025","journal-title":"Gastrointest. Endosc."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/j.gie.2023.02.026","article-title":"A Real-Time Interpretable Artificial Intelligence Model for the Cholangioscopic Diagnosis of Malignant Biliary Stricture (with Videos)","volume":"98","author":"Zhang","year":"2023","journal-title":"Gastrointest. Endosc."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1016\/j.gie.2022.08.021","article-title":"Identification of Patients with Malignant Biliary Strictures Using a Cholangioscopy-Based Deep Learning Artificial Intelligence (with Video)","volume":"97","author":"Marya","year":"2023","journal-title":"Gastrointest. Endosc."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"719","DOI":"10.1055\/a-2034-3803","article-title":"Artificial Intelligence for Diagnosing Neoplasia on Digital Cholangioscopy: Development and Multicenter Validation of a Convolutional Neural Network Model","volume":"55","author":"Kahaleh","year":"2023","journal-title":"Endoscopy"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1016\/j.gie.2021.08.027","article-title":"Artificial Intelligence for Automatic Diagnosis of Biliary Stricture Malignancy Status in Single-Operator Cholangioscopy: A Pilot Study","volume":"95","author":"Saraiva","year":"2022","journal-title":"Gastrointest. Endosc."},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Saraiva, M.M., Ribeiro, T., Gonz\u00e1lez-Haba, M., Agudo Castillo, B., Ferreira, J.P.S., Vilas-Boas, F., Afonso, J., Mendes, F., Martins, M., and Cardoso, P. (2023). Deep Learning for Automatic Diagnosis and Morphologic Characterization of Malignant Biliary Strictures Using Digital Cholangioscopy: A Multicentric Study. Cancers, 15.","DOI":"10.3390\/cancers15194827"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"5447","DOI":"10.1038\/s41598-025-87279-y","article-title":"Artificial Intelligence for Automatic Diagnosis and Pleomorphic Morphological Characterization of Malignant Biliary Strictures Using Digital Cholangioscopy","volume":"15","author":"Mascarenhas","year":"2025","journal-title":"Sci. Rep."},{"key":"ref_19","first-page":"47","article-title":"Multicenter Validation of a Cholangioscopy Artificial Intelligence System for the Evaluation of Biliary Tract Disease","volume":"58","author":"Marya","year":"2026","journal-title":"Endoscopy"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Marya, N.B., Powers, P.D., Marcello, M., Rau, P., Nasser-Ghodsi, N., Marshall, C., Zivny, J., AbiMansour, J.P., and Chandrasekhara, V. (2026). Classification of Biliary Strictures Using Real-Time Cholangioscopy Artificial Intelligence: The SMART-AI Trial. Clin. Gastroenterol. Hepatol., in press.","DOI":"10.1016\/j.cgh.2026.03.033"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"e00418","DOI":"10.14309\/ctg.0000000000000418","article-title":"Automatic Identification of Papillary Projections in Indeterminate Biliary Strictures Using Digital Single-Operator Cholangioscopy","volume":"12","author":"Ribeiro","year":"2021","journal-title":"Clin. Transl. Gastroenterol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"E262","DOI":"10.1055\/a-1723-3369","article-title":"Automatic Detection of Tumor Vessels in Indeterminate Biliary Strictures in Digital Single-Operator Cholangioscopy","volume":"10","author":"Pereira","year":"2022","journal-title":"Endosc. Int. Open"},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Mascarenhas, M., Afonso, J., Ribeiro, T., Andrade, P., Cardoso, H., and Macedo, G. (2023). The Promise of Artificial Intelligence in Digestive Healthcare and the Bioethics Challenges It Presents. Medicina, 59.","DOI":"10.3390\/medicina59040790"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1016\/j.gie.2021.08.015","article-title":"Digital Single-Operator Cholangioscopy Interobserver Study Using a New Classification: The Mendoza Classification (with Video)","volume":"95","author":"Kahaleh","year":"2022","journal-title":"Gastrointest. Endosc."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"He, K., Zhang, X., Ren, S., and Sun, J. (2016, January 27\u201330). Deep Residual Learning for Image Recognition. Proceedings of the 2016 IEEE Conference on Computer Vision and Pattern Recognition (CVPR), Las Vegas, NV, USA.","DOI":"10.1109\/CVPR.2016.90"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"336","DOI":"10.1007\/s11263-019-01228-7","article-title":"Grad-CAM: Visual Explanations from Deep Networks via Gradient-Based Localization","volume":"128","author":"Selvaraju","year":"2020","journal-title":"Int. J. Comput. Vis."},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Chattopadhay, A., Sarkar, A., Howlader, P., and Balasubramanian, V.N. (2018, January 12\u201315). Grad-CAM++: Generalized Gradient-Based Visual Explanations for Deep Convolutional Networks. Proceedings of the 2018 IEEE Winter Conference on Applications of Computer Vision (WACV), Lake Tahoe, NV, USA.","DOI":"10.1109\/WACV.2018.00097"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1453","DOI":"10.1016\/S0140-6736(07)61602-X","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies","volume":"370","author":"Altman","year":"2007","journal-title":"Lancet"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1016\/j.jss.2013.06.028","article-title":"Sensitivity of Endoscopic Retrograde Cholangiopancreatography Standard Cytology: 10-Year Review of the Literature","volume":"184","author":"Burnett","year":"2013","journal-title":"J. Surg. Res."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"1105","DOI":"10.1016\/j.gie.2019.11.025","article-title":"Digital Single-Operator Peroral Cholangioscopy-Guided Biopsy Sampling versus ERCP-Guided Brushing for Indeterminate Biliary Strictures: A Prospective, Randomized, Multicenter Trial (with Video)","volume":"91","author":"Gerges","year":"2020","journal-title":"Gastrointest. Endosc."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"935","DOI":"10.1016\/j.gie.2020.07.025","article-title":"Vascularity Can Distinguish Neoplastic from Non-Neoplastic Bile Duct Lesions during Digital Single-Operator Cholangioscopy","volume":"93","author":"Oleas","year":"2021","journal-title":"Gastrointest. Endosc."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"e16007","DOI":"10.1200\/JCO.2026.44.16_suppl.e16007","article-title":"Deep Learning\u2013Based Computer-Aided Detection and Diagnosis System for Malignant Biliary Stricture (with Videos)","volume":"44","author":"Tang","year":"2026","journal-title":"J. Clin. Oncol."}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/18\/15\/2410\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T06:04:18Z","timestamp":1785132258000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/18\/15\/2410"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,26]]},"references-count":32,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["cancers18152410"],"URL":"https:\/\/doi.org\/10.3390\/cancers18152410","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,26]]}}}