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World J Gastroenterol. Jan 7, 2027; 33(1): 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, Jin-Yu Qiu, Min Ju, Shao-Ru Cai, Gao-Fei Kang, Pi Guo, Zhi-Liang Tang, Pei-Hua Cao, Ke-Bo Zhong
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
BACKGROUND
Cholangioscopy is an important tool used for minimally invasive biliary surgery, and image quality plays a crucial role in the diagnosis and treatment of biliary lesions. Currently, both digital cholangioscopy and fiberoptic cholangioscopy are widely used in clinical settings. However, from the perspective of clinical diagnostic requirements, few head-to-head studies have compared the two devices.
AIM
To evaluate the efficacy and safety of disposable digital single-operator cholangioscopy (DSOC) in terms of diagnostic and therapeutic procedures.
METHODS
A total of 114 participants were enrolled from January 2022 to December 2022. The participants were randomized at a ratio of 1:1 to the test and control groups. Disposable DSOCs were employed in the test group, whereas reusable fiberoptic single-operator cholangioscopies (FSOCs) were used in the control group. The primary outcome was measured by assessing the image quality compliance rate for clinical diagnostic requirements. The secondary outcome was assessed by score-based device performance.
RESULTS
The image quality compliance rates for clinical diagnostic requirements were observed to be 98.28% in the DSOC group, and 98.21% in the FSOC group (rate difference: 0.0615%; 95% confidence interval: -7.4994% to 7.8518%). 92.9% of the images were graded as excellent in the DSOC group, whereas 16.07% in the FSOC group (P < 0.05). DSOC performed better in terms of the smoothness of insertion and withdrawal, as well as the sealability of the instrument channel and flexibility of the bending section. Additionally, the accessory could cooperate closely with the instrument channel to complete the procedure in the DSOC group (P < 0.05). The overall rate of reported adverse events was 46.6% (27/58) in the DSOC group compared with 51.8% (29/56) in the FSOC group (P > 0.05).
CONCLUSION
DSOC was significantly superior to FSOC in terms of image quality, smoothness, sealability and flexibility. Digital cholangioscopy represents a growing trend in minimally invasive biliary surgery.
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.
