Randomized Controlled Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 7, 2018; 24(9): 1046-1055
Published online Mar 7, 2018. doi: 10.3748/wjg.v24.i9.1046
Effect of polyglycolic acid sheet plus esophageal stent placement in preventing esophageal stricture after endoscopic submucosal dissection in patients with early-stage esophageal cancer: A randomized, controlled trial
Ning-Li Chai, Jia Feng, Long-Song Li, Sheng-Zhen Liu, Chen Du, Qi Zhang, En-Qiang Linghu
Ning-Li Chai, Jia Feng, Long-Song Li, Sheng-Zhen Liu, Chen Du, Qi Zhang, En-Qiang Linghu, Department of Gastroenterology, Chinese PLA General Hospital, Beijing 100853, China
Author contributions: Chai NL and Feng J contributed equally to this article; Linghu EQ contributed to study conception and design; Chai NL and Feng J contributed to data acquisition, analysis, and interpretation; Li LS and Liu SZ drafted the manuscript; Du C and Zhang Q contributed to editing and revising the article; all authors read and approved the manuscript.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Chinese PLA General Hospital.
Clinical trial registration statement: This study is registered on http:// www.chictr.org.cn (No. chictr-inr-16008709).
Informed consent statement: All study participants provided written informed consent prior to study enrolment.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
Data sharing statement: No additional 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/
Correspondence to: En-Qiang Linghu, MD, PhD, Chief Doctor, Department of Gastroenterology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. 0572013@fudan.edu.cn
Telephone: +86-10-55499292 Fax: +86-10-55499292
Received: September 20, 2017
Peer-review started: September 21, 2017
First decision: September 27, 2017
Revised: January 2, 2018
Accepted: January 16, 2018
Article in press: January 16, 2018
Published online: March 7, 2018
ARTICLE HIGHLIGHTS
Research background

Esophageal cancer (EC) is one of the most common carcinomas with high mortality, and more than 30% of EC patients after endoscopic submucosal dissection (ESD) still experience postoperative esophageal stricture, which dramatically decreases the quality of life.

Research motivation

The applications of combinations of two or three treatments in the prevention of esophageal stricture after ESD have been investigated in some studies. However, no study explored the effect of the combination of PGA and stent placement in the prevention of post-ESD esophageal stricture.

Research objectives

This study aimed to assess the effect of PGA plus stent placement vs stent placement alone in the prevention of post-ESD esophageal stricture in early-stage EC patients.

Research methods

About 70 EC patients undergoing ESD were enrolled in this study. Patients were allocated randomly at a 1:1 ratio into a PGA plus stent group (PGA sheet-coated stent placement was performed) and a stent group (only stent placement was performed). All patients were followed, and if dysphagia or other symptoms occurred, endoscopy was performed to examine the esophageal stricture.

Research results

The occurrence rate of esophageal stricture in the PGA plus stent group was lower than that in the stent group. Times of balloon dilatation in the PGA plus stent group were less than those in the stent group. Multivariate logistic analysis suggested that PGA plus stent placement was an independent predictive factor for a lower risk of esophageal stricture, while location in the middle third and circumferential range = 1/1 could independently predict a higher risk of esophageal stricture in EC patients after ESD.

Research conclusions

PGA plus stent placement is more effective in preventing post-ESD esophageal stricture vs stent placement alone in early-stage EC patients.

Research perspectives

The total number of recruited EC patients in the present study was relatively small. And a study with a larger sample size is needed to further confirm the efficacy of PGA plus stent placement in preventing esophageal stricture.