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- Title
Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study.
- Authors
Bang, Chang Seok; Shin, Woon Geon; Seo, Seung In; Choi, Min Ho; Jang, Hyun Joo; Park, Se Woo; Kae, Sea Hyub; Yang, Young Joo; Shin, Suk Pyo; Baik, Gwang Ho; Kim, Hak Yang
- Abstract
<bold>Background: </bold>The optimal treatment regimen or the duration of treatment for an endoscopic submucosal dissection (ESD)-induced gastric ulcer has not been established. The aim of this study was to assess the efficacy of novel proton-pump inhibitor, ilaprazole, for the treatment of ESD-induced gastric ulcer.<bold>Methods: </bold>This was a prospective, open-label, randomized multicenter study. Between June 2015 and March 2018, a total of 176 patients (178 lesions) who underwent ESD for a gastric neoplasm were randomly allocated to receive the oral proton-pump inhibitor ilaprazole 20 mg or rabeprazole 20 mg daily for 8 weeks. The primary outcome was the ulcer healing rate at 4 and 8 weeks.<bold>Results: </bold>A total of 155 (157 lesions) and 154 patients (156 lesions) were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks, 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis) or stage of ulcer (scar stage, 25.6% vs. 17.7%, p = 0.25 at 4 weeks, 92.3% vs. 88.6%, p = 0.59 at 8 weeks in the mITT analysis) between the treatment groups. The quality of ulcer healing was not significantly different between the two groups. No independent predictive factor for higher-quality ulcer healing was found in the multivariate analysis.<bold>Conclusions: </bold>According to this trial, ilaprazole and rabeprazole showed no significant difference in the healing of artificial gastric ulcers. Most of the ulcers achieved complete healing within 4-8 weeks.<bold>Trial Registration: </bold>ClinicalTrial.gov NCT02638584.
- Subjects
STOMACH ulcers; ULCER treatment; ENDOSCOPY; PROTON pump inhibitors; DRUG efficacy; SULFUR compounds; STOMACH tumors; WOUND healing; RESEARCH; RESEARCH methodology; SURGICAL complications; EVALUATION research; MEDICAL cooperation; COMPARATIVE studies; RANDOMIZED controlled trials; PEPTIC ulcer; GASTROINTESTINAL agents; LONGITUDINAL method
- Publication
Surgical Endoscopy & Other Interventional Techniques, 2019, Vol 33, Issue 5, p1376
- ISSN
1866-6817
- Publication type
journal article
- DOI
10.1007/s00464-018-6412-9