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
Processing time: 166 Days and 8.4 Hours
Abstract
AIM

To assess the effect of polyglycolic acid (PGA) plus stent placement compared with stent placement alone in the prevention of post-endoscopic submucosal dissection (ESD) esophageal stricture in early-stage esophageal cancer (EC) patients.

METHODS

Seventy EC patients undergoing ESD were enrolled in this randomized, controlled study. Patients were allocated randomly at a 1:1 ratio into two groups as follows: (1) PGA plus stent group (PGA sheet-coated stent placement was performed); and (2) Stent group (only stent placement was performed). This study was registered on http://www.chictr.org.cn (No. chictr-inr-16008709).

RESULTS

The occurrence rate of esophageal stricture in the PGA plus stent group was 20.5% (n = 7), which was lower than that in the stent group (46.9%, n = 15) (P = 0.024). The mean value of esophageal stricture time was 59.6 ± 16.1 d and 70.7 ± 28.6 d in the PGA plus stent group and stent group (P = 0.174), respectively. Times of balloon dilatation in the PGA plus stent group were less than those in the stent group [4 (2-5) vs 6 (1-14), P = 0.007]. The length (P = 0.080) and diameter (P = 0.061) of esophageal strictures were numerically decreased in the PGA plus stent group, whereas no difference in location (P = 0.232) between the two groups was found. Multivariate logistic analysis suggested that PGA plus stent placement (P = 0.026) was an independent predictive factor for a lower risk of esophageal stricture, while location in the middle third (P = 0.034) and circumferential range = 1/1 (P = 0.028) could independently predict a higher risk of esophageal stricture in EC patients after ESD.

CONCLUSION

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

Keywords: Esophageal cancer; Endoscopic submucosal dissection; Polyglycolic acid plus stent placement; Esophageal stricture

Core tip: This study determines the effect of polyglycolic acid (PGA) plus stent placement compared with stent placement alone in the prevention of post-endoscopic submucosal dissection (ESD) esophageal stricture in early-stage esophageal cancer (EC) patients. Our findings confirm that PGA plus stent placement is more effective in preventing post-ESD esophageal stricture compared with stent placement alone in EC patients with early-stage disease.