Evaluating the efficacy of a novel hemostatic powder compared with traditional treatments in nonvariceal upper GI bleeding: a multicenter, randomized, noninferiority study

Abstract

Background and aims: Hemostatic powders have been rapidly developed and used to treat GI bleeding. We aimed to investigate the noninferiority of the newly developed hemostatic powder (CEGP-003; CGBio, Seongnam, South Korea) compared with conventional endoscopic treatments for nonvariceal upper GI bleeding (NVUGIB).

Methods: This prospective, multicenter, randomized, open-label, controlled trial was conducted at 4 referral institutions. We enrolled consecutive patients who underwent emergency endoscopy for NVUGIB. The patients were randomly assigned to either the CEGP-003 group or the conventional treatment group. In the CEGP-003 group, the hemostatic powder was applied as a spray. Conventional endoscopic treatments included electrical coagulation and use of hemostatic clips.

Results: Between November 2019 and June 2022, 218 patients were enrolled (CEGP-003 group, 108; conventional group, 110). Initial hemostasis was achieved in 104 of 108 patients (96.3%) in the CEGP-003 group and 101 of 110 patients (91.8%) in the conventional treatment group. The CEGP-003 group exhibited a significantly higher recurrent bleeding rate than the conventional treatment group. Multivariate analysis showed that age, duodenum and middle one-third of the stomach, and CEGP-003 use as the initial hemostatic treatment were independent risk factors for recurrent bleeding. No adverse events were associated with CEGP-003.

Conclusions: CEGP-003 demonstrates promise as an initial endoscopic therapy for NVUGIB. However, close monitoring is warranted because of the risk of recurrent bleeding. (Clinical trial registration number: KCT0004655.).