Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2020
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.
Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Controlled hypertension under hemostasis prevents post-gastric endoscopic submucosal dissection bleeding: a prospective randomized controlled trial.Surgical endoscopy · 2021Trial
- Stratified and propensity score matching analysis of the effectiveness of fibrin glue in preventing postoperative bleeding after endoscopic submucosal dissection.Annals of medicine · 2025Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNo 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.
methodsThis 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.
resultsAmong 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).
conclusionsAdministration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding.
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Registered trials
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