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Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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. Trial registration: ClinicalTrial.gov NCT02638584.

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Abbreviations

ESD:

Endoscopic submucosal dissection

PPI:

Proton-pump inhibitor

H. pylori :

Helicobacter pylori

KGSRS:

Korean form of Gastrointestinal Symptom Rating Scale

mITT:

Modified intention-to-treat

PP:

Per-protocol

IQR:

Interquartile range

SD:

Standard deviation

OR:

Odds ratio

CI:

Confidence interval

n:

Number

BMI:

Body mass index

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Funding

This research was supported by IL-YANG Pharmaceutical Co., Ltd.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea

    Chang Seok Bang, Woon Geon Shin, Seung In Seo, Min Ho Choi, Hyun Joo Jang, Se Woo Park, Sea Hyub Kae, Young Joo Yang, Suk Pyo Shin, Gwang Ho Baik & Hak Yang Kim

  2. Institue of New Frontier Research, Hallym University College of Medicine, Chuncheon, South Korea

    Chang Seok Bang

  3. Division of Gastroenterology, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, 150 Seongan-ro, Gangdong-gu, Seoul, 05355, South Korea

    Woon Geon Shin

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  1. Chang Seok Bang
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Contributions

WGS: Conception and design of the study. CSB, WGS, SIS, MHC, HJJ, SPS, YJY, GHB, HYK: Generation, collection, assembly, analysis and/or interpretation of data. CSB: Drafting or revision of the manuscript. WGS: Approval of the final version of the manuscript.

Corresponding author

Correspondence to Woon Geon Shin.

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Disclosures

Chang Seok Bang, Woon Geon Shin, Seung In Seo, Min Ho Choi, Hyun Joo Jang, Se Woo Park, Sea Hyub Kae, Young Joo Yang, Suk Pyo Shin, Gwang Ho Baik, and Hak Yang Kim have no conflict of interest or financial ties to disclose.

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Bang, C.S., Shin, W.G., Seo, S.I. et al. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc 33, 1376–1385 (2019). https://doi.org/10.1007/s00464-018-6412-9

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