Basic Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Jun 27, 2021; 13(6): 563-573
Published online Jun 27, 2021. doi: 10.4240/wjgs.v13.i6.563
Efficacy of hybrid endoscopic submucosal dissection with SOUTEN in gastric lesions: An ex vivo porcine model basic study
Mitsuru Esaki, Eikichi Ihara, Norikazu Hashimoto, Shuichi Abe, Chihoko Aratono, Noriko Shiga, Yorinobu Sumida, Hiroyuki Fujii, Kazuhiro Haraguchi, Shunsuke Takahashi, Tsutomu Iwasa, Kayoko Nakano, Masafumi Wada, Shinichi Somada, Kei Nishioka, Yosuke Minoda, Haruei Ogino, Yoshihiro Ogawa
Mitsuru Esaki, Eikichi Ihara, Masafumi Wada, Kei Nishioka, Yosuke Minoda, Haruei Ogino, Yoshihiro Ogawa, Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
Eikichi Ihara, Department of Gastroenterology and Metabolism, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
Norikazu Hashimoto, Shunsuke Takahashi, Department of Gastroenterology, Fukuoka City Hospital, Fukuoka 811-1394, Japan
Shuichi Abe, Kazuhiro Haraguchi, Department of Gastroenterology, Harasanshin Hospital, Fukuoka 812-0033, Japan
Chihoko Aratono, Hiroyuki Fujii, Department of Gastroenterology and Hepatology, National Hospital Organization Fukuokahigashi Medical Center, Koga 811-3195, Japan
Noriko Shiga, Tsutomu Iwasa, Department of Gastroenterology, Fukuokaken Saiseikai Futsukaichi Hospital, Futsukaichi 811-8516, Fukuoka, Japan
Yorinobu Sumida, Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka 810-8564, Japan
Kayoko Nakano, Department of Gastroenterology, Fukuoka Central Hospital, Fukuoka 805-0050, Japan
Shinichi Somada, Department of Gastroenterology, National Hospital Organization Beppu Medical Center, Beppu 874-0011, Japan
Author contributions: Esaki M, Ihara E, Hashimoto N, Wada M, and Minoda Y designed the research; Esaki M drafted the article; Fujii H, Haraguchi K, Takahashi S, Iwasa T, Nakano K, Ogino H, and Ogawa Y revised article for important intellectual content; All authors approved the final version of the article.
Conflict-of-interest statement: Eikichi Ihara participated in the funded research of Takeda Pharmaceutical Co., Ltd. and belongs to the endowed course supported by the companies mentioned, including Ono Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co. Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., Otsuka Pharmaceutical Factory, Inc., Fujifilm Medical Co., Ltd., Termo Corporation, Fancl Corporation, and Ohga Pharmacy. Eikichi Ihara received a lecture fee from Takeda Pharmaceutical Co. Yoshihiro Ogawa is conducting a joint study with Fancl Corporation and Fujifilm Medical Co., Ltd. Other authors have no conflicts of interest or financial ties to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset are available from the corresponding author.
ARRIVE guidelines statement: The authors have read the ARRIVE guidelines, and the manuscript was prepared and revised according to the ARRIVE guidelines.
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: Eikichi Ihara, MD, PhD, Associate Professor, Department of Gastroenterology and Metabolism, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. eikichi@intmed3.med.kyushu-u.ac.jp
Received: February 9, 2021
Peer-review started: February 9, 2021
First decision: May 4, 2021
Revised: May 7, 2021
Accepted: June 16, 2021
Article in press: June 16, 2021
Published online: June 27, 2021
Processing time: 129 Days and 4.2 Hours
Abstract
BACKGROUND

Hybrid endoscopic submucosal dissection (ESD) that comprises mucosal incision and partial submucosal dissection followed by snaring in a planned manner, has been developed for endoscopic resection of gastrointestinal neoplasms to overcome the technical barrier of ESD. Although the superiority of hybrid ESD with SOUTEN, a single multifunctional device, over conventional ESD has been indicated, the actual effect of snaring itself remains unclear since SOUTEN could be applied to hybrid ESD group, but not to the conventional ESD group, due to ethical issue in clinical practice.

AIM

To determine whether and how hybrid ESD was superior to conventional ESD in the endoscopic treatment of gastric lesions in an ex vivo porcine model basic study.

METHODS

Sixteen endoscopists participated in this basic study in August 2020 at Kyushu University, performing 32 procedures each for hybrid ESD and conventional ESD. Mock lesions (10-15 mm, diameter) were created in the porcine stomach. The primary outcome was total procedure time and secondary outcomes were en bloc or complete resection, perforation, procedure time/speed for both, mucosal incision, and submucosal dissection. Factors associated with difficulty in ESD including longer procedure time, incomplete resection, and perforation, were also investigated. Categorical and continuous data were analyzed using the chi-square test or Fisher’s exact test and the Mann-Whitney U test, respectively.

RESULTS

The median total procedure time of hybrid ESD was significantly shorter than that of conventional ESD (median: 8.3 min vs 16.2 min, P < 0.001). Time, speed, and the amount of hyaluronic acid during submucosal dissection were more favorable in hybrid ESD than conventional ESD (time, 5.2 min vs 10.4 min, P < 0.001; speed, 43.7 mm2/min vs 23.8 mm2/min, P < 0.00; injection volume, 1.5 mL vs 3.0 mL, P < 0.001), although no significant differences in those factors were observed between both groups during mucosal incision. There was also no significant difference between both groups in the en bloc/complete resection rate and perforation rate (complete resection, 93.8% vs 87.5%, P = 0.67; perforation, 0% vs 3.1%, P = 1). Selection of conventional ESD as the treatment method was significantly associated with difficulties during ESD (odds ratio = 10.2; highest among factors).

CONCLUSION

Hybrid ESD with SOUTEN improves the treatment outcomes of gastric lesions. It also has the potential to reduce medical costs since SOUTEN is a single multifunctional device that is inexpensive.

Keywords: Endoscopic mucosal resection; Hybrid; Stomach neoplasms; Treatment outcome; Animal experimentation; Logistic models

Core Tip: Hybrid endoscopic submucosal dissection (ESD) is an intermediate technique between endoscopic mucosal resection (EMR) and ESD, which has been developed to overcome the curative barrier of EMR and the technical barrier of ESD in treating gastrointestinal neoplasms. We conducted an ex vivo porcine model basic study to determine the superiority of hybrid ESD with SOUTEN over conventional ESD in treating gastric lesions. The 32 outcomes of each hybrid ESD and conventional ESD were compared. Hybrid ESD had a significantly shorter total procedure time, favorable curability, and low complication rates, compared to conventional ESD. Hybrid ESD with SOUTEN could reduce the costs of ESD.