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

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.