Prospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Nov 7, 2020; 26(41): 6475-6487
Published online Nov 7, 2020. doi: 10.3748/wjg.v26.i41.6475
Third-look endoscopy prevents delayed bleeding after endoscopic submucosal dissection under antithrombotic therapy
Ryosuke Ikeda, Kingo Hirasawa, Chiko Sato, Yuichiro Ozeki, Atsushi Sawada, Masafumi Nishio, Takehide Fukuchi, Ryosuke Kobayashi, Makomo Makazu, Masataka Taguri, Shin Maeda
Ryosuke Ikeda, Chiko Sato, Yuichiro Ozeki, Atsushi Sawada, Masafumi Nishio, Takehide Fukuchi, Ryosuke Kobayashi, Makomo Makazu, Endoscopy Division, Yokohama City University Medical Center, Yokohama 232-0024, Japan
Kingo Hirasawa, Endoscopy Division, Yokohama Medical University Center Hospital, Yokohama 232-0024, Japan
Masataka Taguri, Department of Data Science, Yokohama City University School of Data Science, Yokohama 236-0004, Japan
Shin Maeda, Division of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan
Author contributions: Hirasawa K and Ikeda R contributed to conception and design; Hirasawa K, Ikeda R, Ozeki Y, Sawada A, Nishio M, Fukuchi T, Kobayashi R, Makazu M, and Sato C contributed to acquisition of data; Hirasawa K and Ikeda R contributed to analysis and interpretation of data; Hirasawa K contributed to drafting of the article; Hirasawa K and Maeda S contributed to critical revision of the article; Hirasawa K, Ikeda R, and Taguri M contributed to statistical analysis; Hirasawa K and Maeda S approved the final draft of the article; all authors listed have contributed substantially to the design, data collection and analysis, and editing of the manuscript.
Institutional review board statement: The research ethics committee in our hospital approved this research (Approval number: B170800063) in December 2016.
Clinical trial registration statement: The study was registered at UMIN Clinical Trials Registry System, using identifier 000025607. Details can be found at https://www.umin.ac.jp/ctr/.
Informed consent statement: All patients enrolled in this study provided written informed consent before undergoing endoscopic submucosal dissection.
Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest to disclose.
Data sharing statement: There is no additional data 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: Kingo Hirasawa, MD, PhD, Chief Doctor, Endoscopy Division, Yokohama Medical University Center Hospital, 4-57, Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. kingo-h@urahp.yokohama-cu.ac.jp
Received: June 26, 2020
Peer-review started: June 26, 2020
First decision: September 12, 2020
Revised: September 22, 2020
Accepted: October 20, 2020
Article in press: October 20, 2020
Published online: November 7, 2020
Processing time: 132 Days and 22.8 Hours
Abstract
BACKGROUND

Postoperative delayed bleeding (PDB) after gastric endoscopic submucosal dissection (ESD) is the most common adverse event in patients receiving antithrombotics even with second-look endoscopy. Moreover, with the increasing prevalence of cardiovascular and cerebrovascular diseases in an aging population with associated lifestyle-related diseases, an increasing number of patients receive antithrombotics. Several attempts have been made to prevent PDB in aging population; however, a consensus has yet to be reached.

AIM

To examine the efficacy of third-look endoscopy (TLE) for PDB prevention.

METHODS

One hundred patients with early gastric neoplasms receiving antithrombotics were prospectively enrolled and subjected to ESD with TLE between February 2017 and July 2019. The primary endpoint was PDB rate, which was compared with our preset threshold. Furthermore, we divided the bleeding period into early-and late-onset PDB (E-PDB and L-PDB, respectively) and analyzed its rate. As a secondary analysis, we compared PDB rates with those of a historical control group, using propensity score matching, and calculated the PDB rates per antithrombotic agent use in each group.

RESULTS

In total, 96 patients and 114 specimens were finally evaluated. The overall PDB rate was 7.9% (9/114) [90%CI: 4.7-13.1, P = 0.005], while the late-and early-onset PDB rates (L-PDB and E-PDB) were 5.3% [90%CI: 2.7-9.9, P < 0.0001] and 2.6% [90%CI: 1.1-6.4, P = 0.51], respectively. Propensity score matching generated 58 matched pairs for TLE and control groups. No differences were found in overall PDB incidence (10.3% vs 20.7%, P = 0.12), whereas L-PDB occurrence significantly differed (5.2% vs 17.2%, P = 0.04) between groups. Considering antithrombotics’ use, the overall PDB rate was higher for direct oral anticoagulants and multiple antithrombotics in the control group, while L-PDB incidence was lower in the TLE group for these agents (8.7% vs 23.1% and 5.0% vs 29.4%, respectively).

CONCLUSION

TLE for gastric ESD reduces overall PDB, and especially L-PDB incidence, among patients receiving antithrombotics.

Keywords: Endoscopic submucosal dissection; Postoperative delayed bleeding; Third look endoscopy; Antithrombotic agents; Late phase bleeding; Phase II

Core Tip: The major adverse event after endoscopic submucosal dissection for early gastric cancer under antithrombotic therapy is post-operative delayed bleeding (PDB). We verified the effectiveness of third-look endoscopy (TLE) before discharge in a phase II trial. Our results suggest that TLE significantly reduced PDB incidence among patients who continued to receive antithrombotic drugs. We concluded that TLE which is manageable for every endoscopist is a simple and effective method for preventing PDB under antithrombotic therapy.