Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding

Background & Aims Hemostatic powders have been clinically used in the treatment of gastrointestinal bleeding. We investigated the non-inferiority of a polysaccharide hemostatic powder (PHP), compared with conventional endoscopic treatments, for peptic ulcer bleeding (PUB). Methods This study was a prospective multi-center, randomized, open-label, controlled trial at 4 referral institutions. We consecutively enrolled patients who had undergone emergency endoscopy for PUB. The patients were randomly assigned to either a PHP or conventional treatment group. In the PHP group, diluted epinephrine was injected, and the powder was applied as a spray. Conventional endoscopic treatment included the use of electrical coagulation or hemoclipping after injection of diluted epinephrine. Results Between July 2017 and May 2021, 216 patients were enrolled in this study (PHP group, 105; control group, 111). Initial hemostasis was achieved in 92 of 105 patients (87.6%) in the PHP group and 96 of 111 patients (86.5%) in the conventional treatment group. Re-bleeding did not differ between the 2 groups. In subgroup analysis, the initial hemostasis failure rate in the conventional treatment group was 13.6% for Forrest IIa cases; however, there was no initial hemostasis failure in the PHP group (P = .023). Large ulcer size (≥15 mm) and chronic kidney disease with dialysis were independent risk factors for re-bleeding at 30 days. No adverse events were associated with PHP use. Conclusions PHP is not inferior to conventional treatments and could be useful in initial endoscopic treatment for PUB. Further studies are needed to confirm the re-bleeding rate of PHP. ClinicalTrials.gov, Number: NCT02717416). Hemostatic powders have been clinically used in the treatment of gastrointestinal bleeding. We investigated the non-inferiority of a polysaccharide hemostatic powder (PHP), compared with conventional endoscopic treatments, for peptic ulcer bleeding (PUB). This study was a prospective multi-center, randomized, open-label, controlled trial at 4 referral institutions. We consecutively enrolled patients who had undergone emergency endoscopy for PUB. The patients were randomly assigned to either a PHP or conventional treatment group. In the PHP group, diluted epinephrine was injected, and the powder was applied as a spray. Conventional endoscopic treatment included the use of electrical coagulation or hemoclipping after injection of diluted epinephrine. Between July 2017 and May 2021, 216 patients were enrolled in this study (PHP group, 105; control group, 111). Initial hemostasis was achieved in 92 of 105 patients (87.6%) in the PHP group and 96 of 111 patients (86.5%) in the conventional treatment group. Re-bleeding did not differ between the 2 groups. In subgroup analysis, the initial hemostasis failure rate in the conventional treatment group was 13.6% for Forrest IIa cases; however, there was no initial hemostasis failure in the PHP group (P = .023). Large ulcer size (≥15 mm) and chronic kidney disease with dialysis were independent risk factors for re-bleeding at 30 days. No adverse events were associated with PHP use. PHP is not inferior to conventional treatments and could be useful in initial endoscopic treatment for PUB. Further studies are needed to confirm the re-bleeding rate of PHP. ClinicalTrials.gov, Number: NCT02717416).