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Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

No consensus has been achieved on optimal perioperative strategies for patients undergoing endoscopic submucosal dissection (ESD). The aim of this study was to investigate the effects of an intravenous (IV) proton pump inhibitor (PPI) given during the fasting period after ESD on delayed bleeding following ESD.

Methods

This study was designed as a prospective, randomized, double-blind, placebo-controlled trial in a single center. A total of 235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018 were randomized into a PPI group and placebo group. Patients were administrated intravenous pantoprazole 40 mg daily (PPI group) or placebo (placebo group) during the fasting period 48 h after ESD (from the day of ESD to the following day, 48 h). After oral feeding (48 h after ESD), oral PPI was given to both groups for 8 weeks.

Results

Among 235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis, there was no significant difference between the PPI and control groups in major bleeding (PPI vs. placebo; 3.3% vs. 1.7%, p = 0.27) or minor bleeding (PPI vs. placebo; 7.6% vs. 4.3%, p = 0.41) after ESD. There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups. The only independent risk factor for major delayed bleeding was the combined use of aspirin and antiplatelet agent (OR; 12.25, 95% CI; 1.06–141.19, p = 0.04).

Conclusions

Administration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding.

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Acknowledgment

All authors meet all 4 criteria

1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work

2. Drafting the work or revising it critically for important intellectual content

3. Final approval of the version to be published

4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Funding

This work was supported by the research fund of Hanyang University (HY-2015)

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Author notes

  1. Dong Hee Koh and Hang Lak Lee contributed equally to this work.

Authors and Affiliations

  1. Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea

    Jai Hoon Yoon, Kang Nyeong Lee, Dae Won Jun & Hang Lak Lee

  2. Division of Infectious disease, Department of Internal medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    Youn Jeong Kim

  3. Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, South Korea

    Dong Hee Koh

  4. Department of Gastroenterology, Hanyang University Hospital, Sungdonggu Hangdangdong 17, Seoul, 133-070, South Korea

    Hang Lak Lee

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  1. Jai Hoon Yoon
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Correspondence to Hang Lak Lee.

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Ethical Approval

The study protocol was approved by the Ethics Committee of Hanyang University Medical Center.

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Yoon, J.H., Kim, Y.J., Lee, K.N. et al. Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. J Gastrointest Surg 24, 2596–2601 (2020). https://doi.org/10.1007/s11605-019-04466-9

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  • DOI: https://doi.org/10.1007/s11605-019-04466-9

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