Prospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Mar 16, 2024; 16(3): 168-174
Published online Mar 16, 2024. doi: 10.4253/wjge.v16.i3.168
Using a novel hemostatic peptide solution to prevent bleeding after endoscopic submucosal dissection of a gastric tumor
Kuniyo Gomi, Yorimasa Yamamoto, Erika Yoshida, Misako Tohata, Masatsugu Nagahama
Kuniyo Gomi, Yorimasa Yamamoto, Erika Yoshida, Misako Tohata, Masatsugu Nagahama, Department of Gastroenterology, Showa University Fujigaoka Hospital, Yokohama 227-8501, Kanagawa, Japan
Author contributions: Gomi K and Yamamoto Y designed the research study; Gomi K, Yamamoto Y, Yoshida E and Tohata M performed the research; Gomi K and Nagahama M analyzed the data and wrote the manuscript; All authors have read and approve the final manuscript.
Institutional review board statement: This study was reviewed and approved by the Showa University Institutional Review Board (2023-052-A).
Clinical trial registration statement: The clinical trial is registered with UMIN Clinical Trials Registry, using identifier UMIN000053481. Details can be found at https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000061029.
Informed consent statement: All study participants or their legal guardians, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Kuniyo Gomi, MD, PhD, Assistant Professor, Department of Gastroenterology, Showa University Fujigaoka Hospital, 1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Japan. kunxaqua@med.showa-u.ac.jp
Received: December 19, 2023
Peer-review started: December 19, 2023
First decision: January 4, 2024
Revised: January 9, 2024
Accepted: January 31, 2024
Article in press: January 31, 2024
Published online: March 16, 2024
Processing time: 86 Days and 1.9 Hours
ARTICLE HIGHLIGHTS
Research background

Endoscopic mucosal dissection (ESD) has become the standard of care for early gastric cancer, but bleeding from ulcers after ESD occurs in 4.4% of patients. We aim to minimize post-ESD bleeding to the greatest extent possible. PuraStat (3D-Matrix Europe Ltd., France) is a novel hemostatic peptide solution aiming to reduce the need for cautery with hemostatic forceps in treating exudative bleeding during gastrointestinal endoscopy. We hypothesized that applying PuraStat to gastric ulcers after ESD could prevent post-ESD bleeding.

Research motivation

Reducing post-ESD bleeding is a crucial goal. If PuraStat can be applied to post-ESD gastric ulcers to prevent post-ESD bleeding, it may have broader applications in gastrointestinal bleeding.

Research objectives

The purpose of this study is to determine whether the application of PuraStat to gastric ulcers after ESD can prevent post-ESD bleeding.

Research methods

From May 2022 to March 2023, 101 patients (Group P) who underwent ESD for gastric diseases at our hospital received PuraStat (2 mL) applied to their post-ESD ulcer. We retrospectively compared this group with a control group (Group C) comprising 297 patients who underwent ESD for gastric diseases at our hospital between April 2017 and March 2021. Post-ESD bleeding was the primary endpoint, while the secondary endpoints included the number of days from ESD to post-ESD bleeding and adverse events associated with PuraStat administration.

Research results

Post-ESD bleeding occurred in 6 (5.9%) (95%CI: 2.8–12.4) and 20 (6.7%) (95%CI: 4.4–10.2) patients in Groups P and C, respectively, with no significant between-group difference. The relative risk was 1.01 (95%CI: 0.95–1.07). Therefore, PuraStat application was not associated with post-ESD bleeding. The lesser curvature or anterior wall was the bleeding site in all 5 patients who experienced postoperative bleeding in the PuraStat group. This suggests that gravitational forces may affect the efficacy of applied PuraStat. Specifically, PuraStat seemed less effective for lesions on the anterior wall and lesser curvature than those on the greater curvature and posterior wall. Adjusting the patient’s position during its application could potentially enhance PuraStat’s effectiveness by preventing the hemostatic material from flowing away from the targeted area.

Research conclusions

PuraStat application is not associated with post-ESD bleeding.

Research perspectives

We infer that gravitational forces may affect the efficacy of applied PuraStat. Hence, we aim to explore and develop strategies to prevent PuraStat from flowing away from the targeted areas of interest in further investigation.