Gomi K, Yamamoto Y, Yoshida E, Tohata M, Nagahama M. Using a novel hemostatic peptide solution to prevent bleeding after endoscopic submucosal dissection of a gastric tumor. World J Gastrointest Endosc 2024; 16(3): 168-174 [PMID: 38577651 DOI: 10.4253/wjge.v16.i3.168]
Corresponding Author of This Article
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
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Prospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
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).
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
Abstract
BACKGROUND
Endoscopic mucosal dissection has become the standard treatment for early gastric cancer. However, post-endoscopic submucosal dissection (ESD) ulcer occurs in 4.4% of patients. This study hypothesized whether applying PuraStat, a novel hemostatic peptide solution, prevents post-ESD bleeding.
AIM
To investigate the preventive potential of PuraStat, a hemostatic formulation, against bleeding in post-ESD gastric ulcers.
METHODS
Between May 2022 and March 2023, 101 patients (Group P) underwent ESD for gastric diseases at our hospital and received PuraStat (2 mL) for post-ESD ulcers. 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. P values < 0.05 on two-sided tests indicated significance.
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). The lesser curvature or anterior wall was the bleeding site in all 6 patients who experienced postoperative bleeding in Group P. In multivariate analysis, the odds ratios for resection diameter ≥ 50 mm and oral anticoagulant use were 6.63 (95%CI: 2.52–14.47; P = 0.0001) and 4.04 (1.26–0.69; P = 0.0164), respectively. The adjusted odds ratio of post-ESD bleeding and PuraStat was 1.28 (95%CI: 0.28–2.15).
CONCLUSION
PuraStat application is not associated with post-ESD bleeding. However, the study suggests that gravitational forces may affect the effectiveness of applied PuraStat.
Core Tip: In this investigation, we assessed the potential of PuraStat®, a hemostatic formulation, to prevent bleeding in post-endoscopic submucosal dissection (ESD) gastric ulcers. Application of PuraStat (2 mL) to the post-ESD ulcer in 101 patients who underwent ESD for gastric diseases at our hospital did not exhibit an association with post-ESD bleeding. However, our observations suggest that gravitational forces may affect the efficacy of applied PuraStat. Therefore, we aim to develop strategies to mitigate the risk of PuraStat flowing away from the targeted area of interest in further investigations.
