Retrospective Cohort Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2020; 26(7): 740-748
Published online Feb 21, 2020. doi: 10.3748/wjg.v26.i7.740
Biliary spontaneous dislodgement spiral stent for patients who underwent mechanical lithotripsy
Lian-Song Ye, Xiang-Lei Yuan, Chun-Cheng Wu, Wei Liu, Jiang Du, Ming-Hong Yao, Qing-Hua Tan, Bing Hu
Lian-Song Ye, Xiang-Lei Yuan, Chun-Cheng Wu, Wei Liu, Jiang Du, Qing-Hua Tan, Bing Hu, Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan 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: Ye LS, Yuan XL, Wu CC, Liu W, Du J, Yao MH, Tan QH, and Hu B conceived and designed; Ye LS, Yuan XL, Wu CC, Liu W, Du J, Yao MH, Tan QH, and Hu B analyzed and interpreted the data; Ye LS and Yuan XL drafted the article; Wu CC, Liu W, Du J, Yao MH, Tan QH, and Hu B critically revised the article; Ye LS, Yuan XL, Wu CC, Liu W, Du J, Yao MH, Tan QH and Hu B approved the article.
Supported by Sichuan Science and Technology Program, China, No. 2017SZ0009.
Institutional review board statement: The study protocol was reviewed and approved by the Biomedical Research Ethics Committee, West China Hospital, Sichuan University.
Informed consent statement: Informed consent was waived by the Ethics Committee.
Conflict-of-interest statement: All authors disclose no conflict of interest relevant to this study.
Data sharing statement: No additional unpublished data are available.
STROBE statement: The authors have read the STORBE Statement-checklist of items, and the manuscript was prepared and revised according to the STORBE Statement-checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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, Chief Doctor, Professor, Department of Gastroenterology, West China Hospital, Sichuan University, No. 37, Guo Xue Alley, Wu Hou District, Chengdu 610041, Sichuan Province, China. hubingnj@163.com
Received: November 15, 2019
Peer-review started: November 15, 2019
First decision: December 4, 2019
Revised: December 5, 2019
Accepted: January 11, 2020
Article in press: January 11, 2020
Published online: February 21, 2020
ARTICLE HIGHLIGHTS
Research background

The incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis (PEC) in patients who underwent mechanical lithotripsy (ML) for large stone removal is high (up to 13.3%). One of the main causes is remaining small fragments or sludge that can impair normal biliary drainage. Endoscopic placement of a nasobiliary tube or a conventional plastic biliary stent was commonly used under such conditions, but the patient may suffer from significant discomfort after the placement of a nasobiliary tube, while additional endoscopy is required for stent removal.

Research motivation

We developed a biliary spontaneous dislodgement spiral stent (BSDSS) to overcome nasobiliary tube-related and conventional plastic biliary stent-related shortcomings. The duodenal end of the BSDSS is with several spirals, and its bile duct end has two short and thin flanges. We postulate that the BSDSS is dislodged after papillary edema abates, with the help of bowel movements and/or the passage of high-fiber chyme.

Research objectives

In this retrospective cohort study, we evaluated the feasibility, safety, and effectiveness of inserting a BSDSS for patients who underwent ML for large stone removal by comparing the clinical outcomes of BSDSS patients with those of nasobiliary tube patients.

Research methods

From November 2017 to July 2018, a total of 91 consecutive patients underwent ML for large (≥ 10 mm) stone removal. Of these, 49 patients were eligible for this study, and they were divided into the BSDSS group and the nasobiliary tube group. Technical success, post-ERCP adverse events (including PEC, post-ERCP pancreatitis, stone recurrence, BSDSS retention, self-extraction and dislocation of the nasobiliary tube), drainage time, and postoperative stay were measured and compared.

Research results

Twenty-one patients in the BSDSS group and 28 patients in the nasobiliary tube group were included in the analyses. The baseline characteristics and clinical information were similar in the two groups. Insertions of BSDSS and nasobiliary tube were technically successful in all 49 patients. There was no significant difference in the incidence of overall post-ERCP adverse events between the two groups (4.8% in the BSDSS group vs 17.9% in the nasobiliary tube group, P = 0.219), as well as the median duration of drainage time (3 d in the BSDSS group vs 4 d in the nasobiliary tube group, P = 0.934) and the median length of postoperative stay (4 d in the BSDSS group vs 5 d in the nasobiliary tube group, P = 0.223).

Research conclusions

Endoscopic placement of a BSDSS appears to be feasible, safe and effective for patients who underwent ML for large stone removal.

Research perspectives

Multi-center studies with a large sample size are warranted to further confirm the safety and effectiveness of BSDSS. Comparative study regarding the placement of BSDSS vs no BSDSS is expected to clarify the necessity of routine application of BSDSS in patients who undergo ML for large stone removal.