The Effect of Tegoprazan for Prevention of Iatrogenic Ulcer Bleeding after Endoscopic Submucosal Dissection: A Noninferiority Randomized Clinical Trial.

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) effectively reduce bleeding in patients after endoscopic submucosal dissection (ESD). Tegoprazan, a potassium-competitive acid blocker, provides stronger acid suppression than PPIs do; however, its efficacy in preventing post-ESD bleeding has rarely been studied. The aim of this study was to compare the effects of tegoprazan and pantoprazole on post-ESD bleeding.

METHODS

In this randomized, multicenter trial, patients undergoing ESD for gastric epithelial neoplasms were randomly assigned to two groups; each received tegoprazan (50 mg once daily for 28 days) or pantoprazole (40 mg intravenously for 48 hours and orally once daily for 26 days). Adverse events and serum gastrin levels were assessed as safety outcomes.

RESULTS

The per-protocol set comprised 238 patients (117 tegoprazan, 121 pantoprazole). Noninferiority (within an 8.3% margin) in the post-ESD bleeding rates within 4 weeks was confirmed (risk difference, -6.30%; 95% confidence interval [CI], -14.67% to 2.07%; p=0.0003), with rates of 9.40% (11/117) and 15.70% (19/121) for the tegoprazan and pantoprazole groups, respectively. The bleeding rates within 24 hours were 5.98% (7/117) and 10.74% (13/121), respectively (risk difference, -4.76%; 95% CI, -11.75% to 2.23%). No significant differences were observed in adverse events or serum gastrin levels between the groups.

CONCLUSIONS

Tegoprazan was non-inferior to pantoprazole in its effectiveness in preventing post-ESD bleeding, with comparable safety profiles. Notably, administering oral tegoprazan can potentially shorten the length of hospital stay and reduce medical costs, supporting its potential clinical value. Tegoprazan is expected to replace high-dose intravenous PPI therapy for patients after ESD (CRIS registration: KCT0006850).