Post written by Jun Chul Park, MD, PhD, from the Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, South Korea.

This multicenter, randomized, noninferiority trial evaluated the efficacy and safety of CEGP-003 (CGBio, Seongnam, South Korea)—a novel hemostatic powder composed of hydroxyethylcellulose and epidermal growth factor—compared with that of conventional endoscopic treatments (hemostatic clips/electrical coagulation) in managing nonvariceal upper GI bleeding. The primary outcome was initial hemostasis success, with secondary outcomes including 30-day recurrent bleeding rates and procedural proficiency.

Conventional endoscopic therapies require technical expertise and face limitations in anatomically challenging or diffuse bleeding sites. Hemostatic powders offer advantages such as minimal trauma and ease of application, but prior studies on CEGP-003 were limited to small trials or animal models. This study addressed the gap by conducting, to our knowledge, the first large-scale, prospective randomized controlled trial to validate CEGP-003’s role as a primary treatment for nonvariceal upper GI bleeding, particularly in real-world clinical settings.

CEGP-003 demonstrated noninferiority to conventional treatments, achieving a 96.3% initial hemostatic success rate versus 91.8%. However, a significant drawback emerged: The CEGP-003 group had a higher 30-day recurrent bleeding rate (14.4% vs 2.9%, P = .005). This higher rate was linked to ulcer location and use of the powder. Despite this drawback, CEGP-003 reduced procedure time and difficulty, especially among trainees, suggesting use in resource-limited settings or for less-experienced operators.

Future studies should investigate strategies to reduce recurrence, such as combining CEGP-003 with other therapies, and assess long-term outcomes such as hospital stay duration and cost-effectiveness.

A and B, Endoscopic views showing 2 chronic gastric ulcers with hemorrhage before the application of CEGP-003. C and D, Endoscopic views showing ulcers after the application of CEGP-003.

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