OBJECTIVE: Although metallic hemoclips have been used for hemostasis of bleeding ulcer, there have been few prospective trials to evaluate their efficacy. In this study, a prospective, randomized trial was performed to evaluate endoscopic hemoclipping for bleeding gastric ulcer in comparison with endoscopic injection of absolute ethanol. METHODS: During the period 1995-1998, 126 gastric ulcer patients with bleeding or nonbleeding visible vessel were considered for entry. They were randomly assigned to one of three groups: endoscopic hemostasis performed with injection of absolute ethanol (group I, n = 42), hemoclipping (group II, n = 42), and a combination of the two methods (group III, n = 42). RESULTS: The permanent hemostatic rate was 85.7% in group I, 90.5% in group II, and 92.9% in group III. The mean volume of blood transfusion was 313 +/- 77 ml in group I, 274 +/- 54 ml in group II, and 163 +/- 42 ml in group III, which was significantly less than in groups I or II (p < 0.05). No patients required emergency surgery. Five patients died within a month after initial hemostasis as a result of unrelated conditions. CONCLUSIONS:Endoscopic hemostasis with hemoclips for bleeding gastric ulcer was as effective and safe as that with injection of absolute ethanol, and a combination of ethanol injection and hemoclips did not result in a great advantage over the two individual procedures.
RCT Entities:
OBJECTIVE: Although metallic hemoclips have been used for hemostasis of bleeding ulcer, there have been few prospective trials to evaluate their efficacy. In this study, a prospective, randomized trial was performed to evaluate endoscopic hemoclipping for bleeding gastric ulcer in comparison with endoscopic injection of absolute ethanol. METHODS: During the period 1995-1998, 126 gastric ulcerpatients with bleeding or nonbleeding visible vessel were considered for entry. They were randomly assigned to one of three groups: endoscopic hemostasis performed with injection of absolute ethanol (group I, n = 42), hemoclipping (group II, n = 42), and a combination of the two methods (group III, n = 42). RESULTS: The permanent hemostatic rate was 85.7% in group I, 90.5% in group II, and 92.9% in group III. The mean volume of blood transfusion was 313 +/- 77 ml in group I, 274 +/- 54 ml in group II, and 163 +/- 42 ml in group III, which was significantly less than in groups I or II (p < 0.05). No patients required emergency surgery. Five patients died within a month after initial hemostasis as a result of unrelated conditions. CONCLUSIONS: Endoscopic hemostasis with hemoclips for bleeding gastric ulcer was as effective and safe as that with injection of absolute ethanol, and a combination of ethanol injection and hemoclips did not result in a great advantage over the two individual procedures.