Prospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 28, 2021; 27(8): 725-736
Published online Feb 28, 2021. doi: 10.3748/wjg.v27.i8.725
Endoscopic full-thickness resection using an over-the-scope device: A prospective study
Jin-Tao Guo, Jing-Jing Zhang, Yu-Fan Wu, Ye Liao, Yi-Dan Wang, Bao-Zhen Zhang, Sheng Wang, Si-Yu Sun
Jin-Tao Guo, Jing-Jing Zhang, Yu-Fan Wu, Ye Liao, Yi-Dan Wang, Bao-Zhen Zhang, Sheng Wang, Si-Yu Sun, Department of Gastroenterology, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
Author contributions: Guo JT and Zhang JJ were involved in the study conception and design; Guo JT, Wang S, and Sun SY performed the research; Liao Y, Wu YF, Zhang BZ, and Wang YD analyzed the data; Guo JT wrote the manuscript; Guo JT and Sun SY performed critical revision of the article for important intellectual content; all authors approved the final version of the article.
Supported by National Natural Science Foundation of China, No. 81900601; Innovative Talent Support Program of Liaoning Province, No. LR2019073; and Outstanding Scientific Fund of Shengjing Hospital, No. 201701 and No. 201702.
Institutional review board statement: This study was reviewed and approved by the Internal Review Board and Ethics Committee of China Medical University.
Clinical trial registration statement: The clinical trial is registered with Chinese Clinical Trial Registry, using identifier ChiCTR-OPC-14005459.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript having no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
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: Si-Yu Sun, MD, PhD, Chief Doctor, Director, Professor, Department of Gastroenterology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Shenyang 110004, Liaoning Province, China. sun-siyu@163.com
Received: November 10, 2020
Peer-review started: November 10, 2020
First decision: December 3, 2020
Revised: December 13, 2020
Accepted: January 21, 2021
Article in press: January 21, 2021
Published online: February 28, 2021
Processing time: 100 Days and 19.3 Hours
Abstract
BACKGROUND

Endoscopic submucosal dissection to treat mucosal and submucosal lesions sometimes results in low rates of microscopically margin-negative (R0) resection. Endoscopic full-thickness resection (EFTR) has a high R0 resection rate and allows for the definitive diagnosis and treatment of selected mucosal and submucosal lesions that are not suitable for conventional resection techniques.

AIM

To evaluate the efficacy and safety of EFTR using an over-the-scope clip (OTSC).

METHODS

This prospective, single-center, non-randomized clinical trial was conducted at the endoscopy center of Shengjing Hospital of China Medical University. The study included patients aged 18-70 years who had gastric or colorectal submucosal tumors (SMTs) (≤ 20 mm in diameter) originating from the muscularis propria based on endoscopic ultrasound (EUS) and patients who had early-stage gastric or colorectal cancer (≤ 20 mm in diameter) based on EUS and computed tomography. All lesions were treated by EFTR combined with an OTSC for wound closure between November 2014 and October 2016. We analyzed patient demographics, lesion features, histopathological diagnoses, R0 resection (negative margins) status, adverse events, and follow-up results.

RESULTS

A total of 68 patients (17 men and 51 women) with an average age of 52.0 ± 10.5 years (32-71 years) were enrolled in this study, which included 66 gastric or colorectal SMTs and 2 early-stage colorectal cancers. The mean tumor diameter was 12.6 ± 4.3 mm. The EFTR procedure was successful in all cases. The mean EFTR procedure time was 39.6 ± 38.0 min. The mean OTSC defect closure time was 5.0 ± 3.8 min, and the success rate of closure for defects was 100%. Histologically complete resection (R0) was achieved in 67 (98.5%) patients. Procedure-related adverse events were observed in 11 (16.2%) patients. The average post-procedure length of follow-up was 48.2 ± 15.7 mo. There was no recurrence during follow-up.

CONCLUSION

EFTR combined with an OTSC is an effective and safe technique for the removal of select subepithelial and epithelial lesions that are not amenable to conventional endoscopic resection techniques.

Keywords: Endoscopic full-thickness resection; Over-the-scope clip; Early gastric cancer; Early colorectal cancer; Submucosal tumor; Gastrointestinal stromal tumor

Core Tip: A prospective study of endoscopic full-thickness resection (EFTR) combined with an over-the-scope clip (OTSC) was conducted to assess the treatment of mucosal and submucosal lesions that are not amenable to conventional endoscopic resection techniques. The study had a long follow-up period and included a large number of cases, thus providing statistical strength. We found that EFTR combined with an OTSC was a safe and effective treatment modality for mucosal and submucosal lesions that cannot be treated using conventional endoscopic resection techniques.