Randomized Clinical Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 7, 2022; 28(45): 6397-6409
Published online Dec 7, 2022. doi: 10.3748/wjg.v28.i45.6397
Endoscopic mucosal resection-precutting vs conventional endoscopic mucosal resection for sessile colorectal polyps sized 10-20 mm
Xue-Qun Zhang, Jian-Zhong Sang, Lei Xu, Xin-Li Mao, Bo Li, Wan-Lin Zhu, Xiao-Yun Yang, Chao-Hui Yu
Xue-Qun Zhang, Bo Li, Chao-Hui Yu, Department of Gastroenterology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, Zhejiang Province, China
Jian-Zhong Sang, Department of Gastroenterology, Renmin Hospital of Yuyao City, Yuyao 315499, Zhejiang Province, China
Lei Xu, Department of Gastroenterology, Ningbo First Hospital, Ningbo 315010, Zhejiang Province, China
Xin-Li Mao, Department of Gastroenterology, Taizhou Hospital, Taizhou 317099, Zhejiang Province, China
Wan-Lin Zhu, Department of Gastroenterology, The Central Hospital of Lishui City, Lishui 323020, Zhejiang Province, China
Xiao-Yun Yang, Department of Gastroenterology, Jinhua Municipal Central Hospital, Jinhua 321099, Zhejiang Province, China
Author contributions: Zhang XQ, Xu L, and Yu CH designed the research; Zhang XQ, Sang JZ, Xu L, Mao XL, Li B, Zhu WL, and Yang XY participated in the operation; Zhang XQ and Xu L analyzed the data; Zhang XQ wrote the paper.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of First Affiliated Hospital, School of Medicine, Zhejiang University (No. 20191477); Ningbo First Hospital, Zhejiang (No. 2020-R013) and other participating institutions.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT04191473.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors have no conflicts of interest to declare.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author at zhangxuequn@zju.edu.cn. Participants gave informed consent for data sharing.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Chao-Hui Yu, MD, PhD, Chief Doctor, Professor, Department of Gastroenterology, The First Affiliated Hospital, School of Medicine, Zhejiang University, No. 79 Qingchun Road, Hangzhou 310003, Zhejiang Province, China. zyyyych@zju.edu.cn
Received: July 30, 2022
Peer-review started: July 30, 2022
First decision: September 2, 2022
Revised: September 14, 2022
Accepted: October 19, 2022
Article in press: October 19, 2022
Published online: December 7, 2022
Processing time: 125 Days and 0.9 Hours
ARTICLE HIGHLIGHTS
Research background

The optimal method for removing sessile colorectal lesions sized 10-20 mm remains uncertain. Piecemeal and incomplete resection are major limitations in current practice, including conventional endoscopic mucosal resection (CEMR). Recently, EMR with circumferential precutting (EMR-P) has emerged as an effective technique to overcome the deficiency of EMR. However, the current quality of evidence in comparative studies concerning about CEMR and EMR-P is limited.

Research motivation

To investigate a better method for removing sessile colorectal lesions sized 10-20 mm.

Research objectives

To investigate if EMR-P is superior to CEMR in colorectal lesions sized 10-20 mm.

Research methods

This is a single-blind multicenter randomized controlled trial which involved seven medical institutions in China. The EMR-P was performed following submucosal injection, and a circumferential mucosa incision (precutting) was conducted using a snare tip. The en bloc and R0 resection rate were the primary outcomes analyzed, defined as one-piece resection and one-piece resection with histologically assessed clear margins, respectively.

Research results

In the per-protocol analysis, the en bloc resection rate of EMR-P was significantly higher than CEMR (94.3% vs 86%, P = 0.041), while in subgroup analysis, EMR-P also resulted in a higher en bloc resection rate (92.0% vs 58.8% P = 0.029) for lesions > 15 mm. The R0 resection rate was 81.1% (95%CI: 72.6%-87.4%) in the EMR-P group, higher than in CEMR group (76.6%; 95%CI: 68.8%-84.4%), but without a significant difference between the groups. The EMR-P group had a longer median procedure time (6.4 vs 3.0 min; P < 0.001). No significant difference in the incidence of adverse events was found between the groups (EMR-P: 9.1%; CEMR: 6.4%; P = 0.449).

Research conclusions

EMR-P could serve as an alternative treatment for sessile colorectal polyps sized 10-20 mm.

Research perspectives

The factors affecting the en bloc or R0 resection rate of EMR-P should be further studied, such as the experience of endoscopists, the depth of circumferential incision, the size of the polyp and so on.