BACKGROUND: Although endoscopic hemoclip therapy is widely used in the treatment of GI bleeding, there are few prospective trials that assess its efficacy. This study evaluated the efficacy and safety of hemoclip placement and distilled water injection for the treatment of high-risk bleeding ulcers. METHODS:Seventy-nine patients with major stigmata of ulcer hemorrhage were randomly assigned to either endoscopic hemoclip placement (n = 39) or injection with distilled water (n = 40). RESULTS:Initial hemostasis was achieved in all patients treated with hemoclips and 39 treated by distilled water injection (respectively, 100.0% vs. 97.5%; p = 1.00). Bleeding recurred in 4 and 11 of patients, respectively, in the hemoclip and water injection groups. It occurred significantly more frequently in the injection group (hemoclip, 10.3%; injection, 28.2%; p = 0.04). No major procedure-related complication occurred in either group. Emergency operations were performed in 5.1% of patients treated with hemoclips versus 12.5% of those in the water injection group (p = 0.43). Hospital days and mortality rate were similar in both groups. CONCLUSION:Endoscopic hemoclip placement is a safe and effective hemostatic method that is superior to distilled water injection for treatment of bleeding peptic ulcer.
RCT Entities:
BACKGROUND: Although endoscopic hemoclip therapy is widely used in the treatment of GI bleeding, there are few prospective trials that assess its efficacy. This study evaluated the efficacy and safety of hemoclip placement and distilled water injection for the treatment of high-risk bleeding ulcers. METHODS: Seventy-nine patients with major stigmata of ulcer hemorrhage were randomly assigned to either endoscopic hemoclip placement (n = 39) or injection with distilled water (n = 40). RESULTS: Initial hemostasis was achieved in all patients treated with hemoclips and 39 treated by distilled water injection (respectively, 100.0% vs. 97.5%; p = 1.00). Bleeding recurred in 4 and 11 of patients, respectively, in the hemoclip and water injection groups. It occurred significantly more frequently in the injection group (hemoclip, 10.3%; injection, 28.2%; p = 0.04). No major procedure-related complication occurred in either group. Emergency operations were performed in 5.1% of patients treated with hemoclips versus 12.5% of those in the water injection group (p = 0.43). Hospital days and mortality rate were similar in both groups. CONCLUSION: Endoscopic hemoclip placement is a safe and effective hemostatic method that is superior to distilled water injection for treatment of bleeding peptic ulcer.