Randomized Controlled Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2019; 25(19): 2373-2382
Published online May 21, 2019. doi: 10.3748/wjg.v25.i19.2373
New antireflux plastic stent for patients with distal malignant biliary obstruction
Xiang-Lei Yuan, Bin Wei, Lian-Song Ye, Chun-Cheng Wu, Qing-Hua Tan, Ming-Hong Yao, Yu-Hang Zhang, Xian-Hui Zeng, Yan Li, Yu-Yan Zhang, Bing Hu
Xiang-Lei Yuan, Lian-Song Ye, Chun-Cheng Wu, Qing-Hua Tan, Yu-Hang Zhang, Xian-Hui Zeng, Yan Li, Yu-Yan Zhang, Bing Hu, Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
Bin Wei, Department of Gastroenterology, the First Hospital of Xi’an City, Xi’an 710002, Shaanxi Province, China
Ming-Hong Yao, Department of Epidemiology and Health Statistics, West China School of Public Health, Sichuan University, Chengdu 610041, Sichuan Province, China
Author contributions: Hu B, Yuan XL and Ye LS designed this study; Hu B, Yuan XL, Wu CC, and Tan QH recruited the patients, performed the clinical investigations, and treated the patients; Yuan XL, Wei B, Ye LS, Zhang YH, Zeng XH, Li Y, and Zhang YY participated in trial coordination and monitoring; Yuan XL and Wu CC performed data collection and management; Yuan XL and Yao MH contributed to the statistical analyses; Hu B, Wu CC, and Tan QH analyzed and interpreted the data; Yuan XL and Wei B drafted the manuscript; Hu B, Ye LS, Tan QH, Zhang YH, Zeng XH, Li Y, and Zhang YY critically revised the manuscript; all authors approved the final version of the manuscript for publication.
Supported by the Sichuan Province Science and Technology Department, China, No. 2017SZ0009.
Institutional review board statement: The study protocol was approved by the China Ethics Committee of Registering Clinical Trials (Number: ChiECRCT-20150069; date of approval: December 13, 2015).
Clinical trial registration statement: The trial was registered with Chinese Clinical Trial Registry (Number: ChiCTR-IIR-16007869; date of registration: February 1, 2016).
Informed consent statement: Informed consent was obtained from all patients involved in this study.
Conflict-of-interest statement: Professor Bing Hu is one of the inventors of the antireflux plastic stent. He has worked in collaboration with Micro-Tech (Nanjing) Co. Ltd., Nanjing, China to develop the stent. No free device was offered for this study. The authors disclose no conflicts of interest.
Data sharing statement: No additional unpublished data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Bing Hu, MD, Professor, Department of Gastroenterology, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Wuhou District, Chengdu 610041, Sichuan Province, China. hubingnj@163.com
Telephone: +86-18980601278
Received: March 14, 2019
Peer-review started: March 14, 2019
First decision: March 27, 2019
Revised: March 28, 2019
Accepted: April 19, 2019
Article in press: April 20, 2019
Published online: May 21, 2019
Abstract
BACKGROUND

Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction (MBO). However, the main problem with stent placement is the relatively short duration of stent patency. Although self-expanding metal stents (SEMSs) have a longer patency period than plastic stents (PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS (ARPS) has been proposed. We developed a new ARPS with a “duckbilled” valve attached to the duodenal end of the stent.

AIM

To compare the patency of ARPSs with that of traditional PSs (TPSs) in patients with unresectable distal MBO.

METHODS

We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success, adverse events, and patient survival.

RESULTS

Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events (P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range (IQR), 170], which was significantly longer than that in the TPS group (median, 130 d; IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups (P = 0.900).

CONCLUSION

The new ARPS is safe and effective for the palliation of unresectable distal MBO, and has a significantly longer stent patency than a TPS.

Keywords: Antireflux valve, Plastic biliary stent, Distal malignant biliary obstruction, Stent patency, Endoscopic retrograde cholangiopancreatography

Core tip: There is no ideal design for an antireflux plastic stent for prolonging stent patency. In this study, a newly designed antireflux plastic stent with a “duckbilled” valve was successfully deployed in patients with unresectable distal malignant biliary obstruction. The median duration of stent patency in the antireflux plastic stent group was 285 d, which was significantly longer than that in the traditional plastic stent group (130 d).