Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Mar 27, 2023; 15(3): 440-449
Published online Mar 27, 2023. doi: 10.4240/wjgs.v15.i3.440
Endoscopic mucosal resection with double band ligation versus endoscopic submucosal dissection for small rectal neuroendocrine tumors
Jia-Lan Huang, Ri-Yun Gan, Ze-Han Chen, Ruo-Yu Gao, De-Feng Li, Li-Sheng Wang, Jun Yao
Jia-Lan Huang, Ri-Yun Gan, Ze-Han Chen, Department of Gastroenterology, The Second Clinical Medical College, Jinan University, Shenzhen 518020, Guangdong Province, China
Ruo-Yu Gao, Department of Gastroenterology, Shenzhen Luohu People's Hospital, Shenzhen 518020, Guangdong Province, China
De-Feng Li, Li-Sheng Wang, Jun Yao, Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen 518020, Guangdong Province, China
Author contributions: Yao J was responsible for design of the study and reviewed the manuscript; Huang JL drafted the manuscript; Huang JL, Gan RY, Chen ZH and Gao RY contributed to data acquisition, analysis, and interpretation; Yao J, Li DF and Wang LS were responsible for revising manuscript; All authors have read and approved the final manuscript.
Supported by Technical Research and Development Project of Shenzhen, No. JCYJ20210324113215040.
Institutional review board statement: The study was reviewed and approved by the ethics committee of Shenzhen People's Hospital (Approval No. LL-KY-2022152-01).
Clinical trial registration statement: This study is registered at Chinese Clinical Trial Registry. The registration identification number is ChiCTR2200063871.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at yao.jun@szhospital.com. 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: Jun Yao, MD, PhD, Associate Chief Physician, Associate Professor, Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), 1017 East Gate Road, Shenzhen 518020, Guangdong Province, China. yao.jun@szhospital.com
Received: December 6, 2022
Peer-review started: December 6, 2022
First decision: December 27, 2022
Revised: January 9, 2023
Accepted: February 27, 2023
Article in press: February 27, 2023
Published online: March 27, 2023
Processing time: 110 Days and 22.7 Hours
ARTICLE HIGHLIGHTS
Research background

Endoscopic resection remains an effective method for the treatment of small rectal neuroendocrine tumors (NETs) ( ≤ 10 mm). However, the consensus about the optimal endoscopic treatment modality for rectal NETs has not been established yet.

Research motivation

To overcome the shortcomings of endoscopic mucosal resection(EMR) with band ligation (EMR-B)(EMR-L), we presented a new EMR technique. EMR with double band ligation (EMR-dB), a simplified modification of EMR-B, could achieve a deeper vertical resection margin compared with EMR-B. However, the safety and efficacy of EMR-dB technique in treating small rectal NETs has not been determined.

Research objectives

In the present study, we compared the safety and efficacy of EMR-dB and endoscopic submucosal dissection (ESD) in the treatment of rectal NETs. We aimed to evaluate the feasibility of EMR-dB for the treatment of small rectal NETs ( ≤ 10 mm) in comparison to ESD.

Research methods

A randomized controlled trial comparing EMR-dB and ESD was conducted. The primary outcome was the histological complete resection rate; secondary outcomes included en bloc resection rate, procedure time, complications and so on. Follow-up was also performed.

Research results

A total of 50 patients were analyzed and were 25 patients in each group. The demographic and baseline characteristics of the participants were similar between the two groups, including age, gender, lesion location (average distance from anus), lesion sizes, and resected lesion sizes. histological complete resection and en bloc resection were achieved in all 50 patients. No significant difference in the complication rate between the two groups [delayed bleeding occurred in 0 patients in the EMR-dB group and two patients in the ESD group (8.0%) (P = 0.47)], indicating that EMR-dB is non-inferior to ESD with a similar complete resection rate and complication rate. However, the procedure time was significantly shorter in the EMR-dB group (6.28 ± 0.75 min) compared with the ESD group (14.30 ± 1.51 min) (P < 0.001) and the devices cost was significantly lower in the EMR-dB group than in the ESD group ($ 494.04 ± $ 85.47 vs $ 808.98 ± $ 143.67, P < 0.05), which demonstrated that EMR-dB had shorter procedure duration time and lower operation costs. No local remnant lesions or recurrences were observed during the follow-up period in both groups, further prospective studies with a long-term follow-up period are needed to verify our findings.

Research conclusions

EMR-dB, a new EMR technique presented in our study, took less time than ESD, and displayed a similar curative effect to ESD. If no lymph nodes and distant metastases are revealed by either endoscopic ultrasound or computerized tomography, EMR-dB is a feasible and safe option for the treatment of small rectal NETs.

Research perspectives

First, this study was a single-center study with limited sample size. In addition, considering that rectal NET is a slow-growing tumor, further prospective studies with a long-term follow-up period are needed to verify our findings. Moreover, statistical analysis between EMR-B and EMR-dB can be further investigate.