Prospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Dec 16, 2023; 15(12): 725-734
Published online Dec 16, 2023. doi: 10.4253/wjge.v15.i12.725
New hope for esophageal stricture prevention: A prospective single-center trial on acellular dermal matrix
Xin-Yu Fu, Zhen-Yu Jiang, Chen-Yang Zhang, Ling-Yan Shen, Xiao-Dan Yan, Xiao-Kang Li, Jia-Ying Lin, Yi Wang, Xin-Li Mao, Shao-Wei Li
Xin-Yu Fu, Chen-Yang Zhang, Jia-Ying Lin, Department of Gastroenterology, Taizhou Hospital of Zhejiang Province, Wenzhou Medical University, Linhai 317000, Zhejiang Province, China
Zhen-Yu Jiang, Department of Gastroenterology, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou 014000, Inner Mongolia Autonomous Region, China
Ling-Yan Shen, Xiao-Dan Yan, Yi Wang, Xin-Li Mao, Shao-Wei Li, Department of Gastroenterology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai 317000, Zhejiang Province, China
Xiao-Kang Li, Shao-Wei Li, Key Laboratory of Minimally Invasive Techniques & Rapid Rehabilitation of Digestive System Tumor of Zhejiang Province, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai 317000, Zhejiang Province, China
Xiao-Kang Li, Division of Transplantation Immunology, National Research Institute for Child Health and Development, Tokyo 1540001, Japan
Shao-Wei Li, Institute of Digestive Disease, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, Linhai 317000, Zhejiang Province, China
Co-first authors: Xin-Yu Fu and Zhen-Yu Jiang.
Co-corresponding authors: Shao-Wei Li and Xin-Li Mao.
Author contributions: Fu XY, Zhang CY, Lin JY, Yan XD, Li XK, Wang Y, and Mao XL participated in the design of the study and performed the statistical analysis; Fu XY, Jiang ZY, Zhang CY, Lin JY, and Li SW drafted the manuscript. All authors read and approved the final manuscript.
Supported by Medical Health Science and Technology Project of Zhejiang Province, No. 2021PY083, 2019KY239; Program of Taizhou Science and Technology Grant, No. 23ywa33; Major Research Program of Taizhou Enze Medical Center Grant, No. 19EZZDA2; Open Fund of Key Laboratory of Key Laboratory of Minimally Invasive Techniques & Rapid Rehabilitation of Digestive System Tumor of Zhejiang Province, No. 21SZDSYS01 and No. 21SZDSYS09; Program of Taizhou Enze Medical Center Grant, No. 22EZD06.
Institutional review board statement: This prospective, single-center, controlled study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Taizhou Hospital, Zhejiang Province, under the Institutional Review Board of Wenzhou Medical University (autologous mucosa transplantation approval number: K20190123; ADM transplantation approval number: X20190603).
Clinical trial registration statement: The study was registered with the Center for Clinical Trials under registration number ChiCTR200040119.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: All the authors declare that they have no conflict interests to disclose.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT Statement—checklist of items, and the manuscript was prepared and revised according to the CONSORT 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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Shao-Wei Li, PhD, Associate Professor, Department of Gastroenterology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University, No. 150 Xinmen Street, Linhai 317000, Zhejiang Province, China. li_shaowei81@hotmail.com
Received: August 5, 2023
Peer-review started: August 5, 2023
First decision: October 9, 2023
Revised: October 22, 2023
Accepted: November 3, 2023
Article in press: November 3, 2023
Published online: December 16, 2023
Processing time: 132 Days and 0.1 Hours
Abstract
BACKGROUND

Given the high incidence of esophageal cancer in China, an increasing number of patients there are undergoing endoscopic mucosal dissection (ESD). Although the 5-year survival rate after ESD can exceed 95%, esophageal stricture, the most common and serious postoperative complication, affects the long-term prognosis of patients and the quality of life. Autologous mucosal grafts have proven to be successful in preventing stricture after ESD for early esophageal cancer.

AIM

To examine the viability of acellular dermal matrix (ADM) as an alternative to autologous mucosa for the prevention of stricture after ESD.

METHODS

This is a prospective, single-center, controlled study. Consecutive patients who underwent ESD surgery and were willing to undergo autologous mucosal transplantation were recruited between January 1 and December 31, 2017. Consecutive patients who underwent ESD surgery and were willing to undergo ADM transplantation were recruited between January 1 to December 31, 2019. A final three-year follow-up of patients who received transplants was conducted.

RESULTS

Based on the current incidence of esophageal stricture, the sample size required for both the autologous mucosal graft group and the ADM group was calculated to be 160 cases. Due to various factors, a total of 20 patients with autologous mucosal grafts and 25 with ADM grafts were recruited. Based on the inclusion exclusion and withdrawal criteria, 9 patients ultimately received autologous mucosal grafts and completed the follow-up, while 11 patients received ADM grafts and completed the follow-up. Finally, there were 2 cases of stenosis in the autologous mucosal transplantation group with a stenosis rate of 22.22% and 2 cases of stenosis in the ADM transplantation group with a stenosis rate of 18.18%, with no significant difference noted between the groups (P = 0.94).

CONCLUSION

In this prospective, single-center, controlled trial, we compared the effectiveness of autologous mucosa transplantation and ADM for the prevention of esophageal stricture. Due to certain condition limitations, we were unable to recruit sufficient subjects meeting our target requirements. However, we implemented strict inclusion, exclusion, and withdrawal criteria and successfully completed three years of follow-up, resulting in valuable clinical insights. Based on our findings, we hypothesize that ADM may be similarly effective to autologous mucosal transplantation in the prevention of esophageal stricture, offering a comparable and alternative approach. This study provides a new therapeutic idea and direction for the prevention of esophageal stricture.

Keywords: Over-the-scope clip; Duodenal subepithelial lesion; Endoscopic resection; Perforation

Core Tip: Preventing esophageal stricture after endoscopic submucosal dissection (ESD) is a critical challenge in the successful treatment of early esophageal cancer. Acellular dermal matrix (ADM) has recently emerged as a potential solution. This study showed that the preventive effect of ADM on esophageal stricture was comparable to that of autologous mucosa. Despite the study's limited sample size, it includes improved postoperative follow-up and holds clinical significance. The results validate ADM as a viable alternative for preventing esophageal stricture. These findings will potentially revolutionize ESD treatment for early esophageal cancer and provide safer and more accessible options for such patients.