Advanced search

Treatment with vonoprazan for 3 weeks is not inferior to 8 weeks for the management of gastric ESD: a multicenter noninferiority randomized study.

Yasuo Miyamoto, Takanori Kanai, Naohisa Yahagi, Kenichi Yoshimura, Yoko Kubosawa, Ryohei Kishino, Akiko Ohno, Yuichi Morohoshi, Hideki Mori, Toshiki Horii, Motohiko Kato, Takafumi Ito, Hiroyuki Imaeda, Yukishige Okamura, Yoshiaki Kimoto, Hideo Yoshida, Mizuki Kuramochi, Chika Kusano, Takuji Gotoda, Naoki Hosoe

Journal: Journal of gastroenterology 2023;58(4):358-366

PMID: 36781490

Full Text on Springer View on PubMed

Abstract

BACKGROUND

Vonoprazan, a potassium-competitive acid blocker (VPZ), significantly reduces postoperative bleeding after gastric ESD; however, there is no consensus on the appropriate treatment duration. We conducted a randomized controlled study to demonstrate that the 3-week administration of VPZ is not inferior to the 8-week administration for ulcer healing.

METHODS

This is a prospective, open-label multicenter randomized controlled trial. Patients aged 20-85 years undergoing gastric ESD were included in this study. The key exclusion criteria were patients with bleeding tendencies and those taking NSAIDs, steroids, PPIs, or VPZ medications. Eligible patients were randomly assigned to the VPZ 3w or 8w treatment group. The primary endpoint was the proportion of patients with complete closure of the post-ESD wound at 24 weeks after ESD. The key secondary endpoints included the proportion of patients with complete closure of the post-ESD wound at 8 weeks and the proportion of bleeding or perforation more than 3 weeks after ESD.

RESULTS

From May 2018 to October 2020, 234 patients were included. The proportion of patients with complete ulcer closure was significantly lower in the 3w group than in the 8w group (70.8% vs. 90.6%) at 8 weeks post-treatment. The complete closure rates at 24 weeks in the 3w and 8w groups were 99.1% and 99.2%, respectively. The absolute difference in the closure rate at 24 weeks was - 0.059% [95% confidence interval (CI) -3.4% to 3.2], and the lower limit of the 95% CI exceeded -10%, the preset threshold. None of the patients developed delayed bleeding 3 weeks after ESD.

CONCLUSION

This multicenter randomized study demonstrated that 3 weeks of treatment with VPZ is sufficient for ulcer healing. Trial registry number. UMIN000031564.

© 2023. Japanese Society of Gastroenterology.

Address: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. [email protected].; Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan. [email protected].; Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.; Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.; Department of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan.; Department of Gastroenterology and Hepatology, National Hospital Organization Saitama Hospital, Saitama, Japan.; Department of Gastroenterology and Hepatology, Eiju General Hospital, Tokyo, Japan.; Division of Gastrointestinal Endoscopy, NTT Medical Center Tokyo, Tokyo, Japan.; Department of Gastroenterology and Hepatology, Sano Kosei General Hospital, Tochigi, Japan.; Department of Gastroenterology, Saitama Medical University Hospital, Saitama, Japan.; Department of Gastroenterology, Keiyu Hospital, Yokohama, Japan.; Department of Gastroenterology, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.; Department of Gastroenterology, Yuri Kumiai General Hospital, Akita, Japan.; Department of Gastroenterology and Hepatology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.; Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Louvain, Belgium.; Department of Gastroenterology and Hepatology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.; Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.; Department of Internal Medicine, Saiseikai Central Hospital, Tokyo, Japan.; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.; Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan.; Center for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.
DOI: 10.1007/s00535-023-01966-z

Link outs

Free resources

Medical:

Miscellaneous:

Subscription / membership required

Full Text Sources:

MeSH Terms: Humans, Ulcer, Proton Pump Inhibitors, Stomach Ulcer, Prospective Studies, Stomach Neoplasms, Endoscopic Mucosal Resection, Treatment Outcome
Bant logo

© Copyright 2026, Nutrition Evidence

NED wishes to thank the following organisations for their support:

Sponsor Sponsor Sponsor Sponsor Sponsor Sponsor Sponsor

We use cookies to improve your experience and analyze site traffic with Google Analytics. By continuing to use our site, you agree to our use of cookies. Learn more.