Copyright: ©Author(s) 2027. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Gastroenterol. Jan 7, 2027; 33(1): 125390
Published online Jan 7, 2027. doi: 10.3748/wjg.125390
Published online Jan 7, 2027. doi: 10.3748/wjg.125390
Efficacy and safety of disposable digital single-operator cholangioscopy: A noninferiority, multicenter, randomized, open-label, blinded endpoint trial
Yuan Xie, Zhi-Liang Tang, Department of Hepato-Biliary-Pancreatic-Splenic Surgery, The First People's Hospital of Zhaoqing, Zhaoqing 526000, Guangdong Province, China
Jin-Yu Qiu, Department of Clinical Trial Institution, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, Guangdong Province, China
Min Ju, Department of Ear, Nose and Throat, The People’s Hospital of Gaoan, Gaoan 330800, Jiangxi Province, China
Shao-Ru Cai, Gao-Fei Kang, Ke-Bo Zhong, Department of Hepatobiliary Surgery, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, Guangdong Province, China
Pi Guo, Department of Preventive Medicine, Shantou University Medical College, Shantou 515041, Guangdong Province, China
Pei-Hua Cao, Clinical Research Center, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, Guangdong Province, China
Co-first authors: Yuan Xie and Jin-Yu Qiu.
Co-corresponding authors: Pei-Hua Cao and Ke-Bo Zhong.
Author contributions: Xie Y wrote and revised the manuscript; Qiu JY performed data management and quality control; Xie Y and Qiu JY were co-first authors and contributed equally to this work; Ju M, Cai SR, and Kang GF helped to collect the data; Guo P proposed revision suggestions; Tang ZL helped supervise the trial; Cao PH participated in the statistical analysis; Zhong KB designed the study; Cao PH and Zhong KB are co-corresponding authors and contributed equally to this project. All authors have read and approved the final manuscript.
AI contribution statement: No AI tool was used to generate research data, interpret results, or formulate conclusions.
Supported by Guangdong S&T Program, No. 2025B1111110001; National Key R&D Program of China, No. 2022YFA1104900; and 2022 Artificial Liver Special Fund of the Beijing Liver and Gallbladder Health Public Welfare Foundation, No. iGandanF-1082022-RGG053.
Institutional review board statement: The study was reviewed and approved by the Medical Ethics Committee of Zhujiang Hospital, Southern Medical University, No. 2022-QX-004-01.
Clinical trial registration statement: This trial was registered at the Chinese Clinical Trial Registry website (https://www.chictr.org.cn), No. ChiCTR2600127409.
Informed consent statement: All study participants, or their legal representatives, provided written informed consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The technical appendix, statistical code, and dataset are available from the corresponding author upon a reasonable request.
Corresponding author: Ke-Bo Zhong, MD, Department of Hepatobiliary Surgery, Zhujiang Hospital, Southern Medical University, No. 253 Gongye Middle Avenue, Haizhu District, Guangzhou 510280, Guangdong Province, China. zhongkb@smu.edu.cn
Received: July 6, 2026
Revised: August 3, 2026
Accepted: September 9, 2026
Published online: January 7, 2027
Processing time: 126 Days and 23.3 Hours
Revised: August 3, 2026
Accepted: September 9, 2026
Published online: January 7, 2027
Processing time: 126 Days and 23.3 Hours
Core Tip
Core Tip: This randomized study compared digital cholangioscopy with fiberoptic cholangioscopy, from the perspective of clinical diagnostic requirements. The results revealed that digital cholangioscopy was significantly superior to fiberoptic cholangioscopy in terms of image quality, smoothness, sealability and flexibility, although the image quality compliance rates for clinical diagnostic requirements were comparable between the procedures. Additionally, the accessory could cooperate better with the instrument channel to complete the digital cholangioscopy procedure. Digital cholangioscopy represents a growing trend in minimally invasive biliary surgery.