Rebleeding From Gastric Varices Clinical Trial
Official title:
A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding
Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.
Previous studies have proven that the use of cyanoacrylate glue injection was superior to
EIS or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue
injection has gained worldwide popularity except the United States. The hemostatic rates of
glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%.
Though histoacryl injection is now regarded as treatment of choice in the control of gastric
variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer
bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On
the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding
gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were
between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without
inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been
reported. The mechanism of hemostasis induced by thrombin is through the conversion of
fibrinogen to fibrin and enhancement of platelets aggregation. This trial aimed to compare
the relative efficacy and safety between histoacryl injection and thrombin injection in the
prevention of gastric variceal rebleeding.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment