An open pilot study of the effects of a human fibrin glue for endoscopic treatment of patients with acute bleeding from gastric varices

Background: Optimal treatment for gastric variceal bleeding remains to be determined. The use of conventional sclerosing agents is associated with high rates of recurrent bleeding. Other agents, such as cyanoacrylate, have significant complication rates and can damage endoscopic equipment. The risk of prior-associated disease has caused concern regarding the use of bovine thrombin. Methods: Beriplast-P (human thrombin) forms a fibrin clot at the needle tip immediately upon injection through a double lumen needle. In 10 patients with gastric variceal bleeding, a median dose of 6 mL of Beriplast-P was injected into gastric varices. Observations: Immediate hemostasis was achieved in 7 of 10 patients (70%) with a single injection. At a median follow-up of 8 months, there was no recorded episode of recurrent bleeding from gastric varices. Conclusions: These results suggest that Beriplast-P is useful in the treatment of gastric variceal bleeding. Refinements in the design of the injection needle may improve the efficacy of this novel therapy.