Portal Hypertension Clinical Trial
Official title:
Efficacy of Early-TIPS in the Treatment of Acute Variceal Bleeding From Gastric Fundal Varices: a RCT vs Standard Therapy
In the last years, important advances have been done in the treatment and prevention of
fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of
pharmacological and endoscopic therapy (with tissue adhesives) should be the first line
therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2
gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic
shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent
variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy
and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal
variceal bleeding showed that an early TIPS, performed during the first 72h after patient
admission resulted in a significant decrease in failure to control bleeding and early and
late rebleeding. Moreover, survival was also significantly increased as well as other
portal-hypertension related complications (ascites, spontaneous bacterial peritonitis,
hepatorenal syndrome, etc).
The present study is directed at comparing the outcome of patients with acute bleeding from
fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic
injection of tissue adhesives) with or without early TIPS (performed during the first 1-5
days after admission). Main end-point will be survival free of variceal rebleeding at 1 year
from inclusion.
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