CEGP-003 Spray Has a Similar Hemostatic Effect to Epinephrine Injection in Cases of Acute Upper Gastrointestinal Bleeding.

Abstract

Endoscopically applicable hemostatic agents have been demonstrated to have high initial hemostasis rates in cases of upper gastrointestinal bleeding (UGIB). The authors developed a new hemostatic powder (CEGP-003) and evaluated its hemostatic and ulcer healing effects in UGIB. Patients with peptic ulcer or post-endoscopic resection bleeding were randomly assigned to be treated by epinephrine injection or CEGP-003 spray. All patients were placed under observation for 3days and underwent second-look endoscopy. The primary outcome was initial hemostasis rate, and the secondary outcomes were rebleeding rate and ulcer healing effect. Seventy-two patients with UGIB were enrolled in this study. Causes of bleeding were peptic ulcer (15, 20.5%), post-endoscopic mucosal resection (11, 15.1%), and post-endoscopic submucosal dissection bleeding (47, 64.4%). Initial hemostasis was achieved in 89.2% (34/37) of patients in the epinephrine group and in 100% (35/35) in the CEGP-003 group (p = 0.115). Rebleeding occurred in 2.7% (1/37) and 8.6% (3/35) in the epinephrine and CEGP-003 groups, respectively (p = 0.35). Three days after endoscopic hemostasis, the ulcer healing effects of epinephrine and CEGP-003 were similar (p = 0.79). This study shows that CEGP-003 spray has a hemostatic effect similar to epinephrine in terms of initial hemostasis and rebleeding rates. The authors consider CEGP-003 a potential therapeutic tool for UGIB as a definitive or bridge therapy and that it is particularly useful for oozing lesions after endoscopic resection.