Basic Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 14, 2019; 25(26): 3370-3379
Published online Jul 14, 2019. doi: 10.3748/wjg.v25.i26.3370
Drug-eluting fully covered self-expanding metal stent for dissolution of bile duct stones in vitro
Chao Huang, Xiao-Bo Cai, Li-Li Guo, Xiao-Sheng Qi, Qiang Gao, Xin-Jian Wan
Chao Huang, Xiao-Bo Cai, Li-Li Guo, Xin-Jian Wan, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201620, China
Chao Huang, Xiao-Bo Cai, Li-Li Guo, Xin-Jian Wan, Shanghai Key Laboratory for Pancreatic Diseases, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201620, China
Xiao-Sheng Qi, Department of General Surgery, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201620, China
Qiang Gao, State Key Laboratory for Modification of Chemical Fibers and Polymer Materials, College of Chemistry, Chemical Engineering and Biotechnology, Donghua University, Shanghai 201620, China
Author contributions: Huang C designed and mainly carried out all the experiments; Qi XS, Guo LL, and Gao Q assisted in carrying out the experiments; Wan XJ supervised the study; Huang C wrote the paper; Wan XJ together with Cai XB revised the article.
Supported by the National Natural Science Foundation of China, No. 81470904; and Shanghai Committee of Science and Technology, No. 14411963000.
Institutional review board statement: This study was approved by the Ethics Committee of Shanghai General Hospital, Shanghai Jiaotong University School of Medicine.
Institutional animal care and use committee statement: All experimental procedures were approved by the Animal Care and Use Committee of Shanghai Jiaotong University School of Medicine.
Conflict-of-interest statement: All authors declare no conflicts of interest related to this article.
Data sharing statement: No additional data are available.
ARRIVE guidelines statement: The authors have read the ARRIVE guidelines, and the manuscript was prepared and revised according to the ARRIVE guidelines.
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: Xin-Jian Wan, PhD, Chief Doctor, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, No. 650, Xinsongjiang Road, Shanghai 201620, China. XinJian_Wan_shsy@163.com
Telephone: +86-21-6324-8460 Fax: +86-21-6324-8460
Received: April 25, 2019
Peer-review started: April 25, 2019
First decision: May 16, 2019
Revised: May 26, 2019
Accepted: May 31, 2019
Article in press: June 1, 2019
Published online: July 14, 2019
Processing time: 80 Days and 20.2 Hours
ARTICLE HIGHLIGHTS
Research background

The treatment of difficult common bile duct stones (CBDS) remains a big challenge around the world and there is no consensus on the management of difficult CBDS.

Research motivation

In our previous studies, we have developed a drug-eluting plastic stent (PS) which is able to release disodium ethylene diamine tetraacetic acid (EDTA) and sodium cholate (SC), and the stent has been proved to effectively dissolve CBDS ex vivo and in a live porcine CBDS model. However, there are several shortcomings in our previous version, thus we aimed to modify our stone-dissolving stents in this study.

Research objectives

This study aimed to manufacture a drug-eluting metal stent, which can achieve controlled release of stone-dissolving agents and speed up the dissolution of CBDS, thus providing a promising alternative for the management of difficult CBDS.

Research methods

In this study, three different methods were used to manufacture the drug-eluting stents. The drug-release behavior and stone-dissolving efficacy of these stents was evaluated in vitro to sort out the best manufacturing method. And the selected stone-dissolving stents were further put into porcine CBD to evaluate their biosecurity.

Research results

We found that the stent manufactured by dip coating combined with electrospinning was characterized by sustainable drug release, better stone-dissolving efficacy, and good biosecurity. However, we failed to establish the CBDS model in miniature pigs and the disintegration of stone caused by mechanical friction between fully covered self-expanding metal stent (FCSEMS) and stone could not be fully evaluated.

Research conclusions

The novel SC and EDTA-eluting FCSEMS is efficient in diminishing CBDS in vitro and is characterized by good biosecurity. The idea of delivering stone-dissolving agents to the location of CBDS via biliary stent is feasible. When conventional endoscopic techniques fail to remove difficult CBDS, SC and EDTA-eluting FCSEMS implantation may be considered a promising alternative.

Research perspectives

In the future research, a live porcine CBDS model needs to be established so that the disintegration of stone caused by mechanical friction between FCSEMS and stone could be fully evaluated. And we can compare which stent works better in disintegrating CBDS, PS, or FCSEMS.