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

ABSTRACT

BACKGROUND: Endoscopically applicable hemostatic agents have been demonstrated to have high initial hemostasis rates in cases of upper gastrointestinal bleeding (UGIB). AIMS: The authors developed a new hemostatic powder (CEGP-003) and evaluated its hemostatic and ulcer healing effects in UGIB. METHODS: 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 3 days and underwent second-look endoscopy. The primary outcome was initial hemostasis rate, and the secondary outcomes were rebleeding rate and ulcer healing effect. RESULTS: 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). CONCLUSION: 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.