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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
TIPS (first 5 days)
Hospital Germans Trias i Pujol
Badalona, Catalonia, Spain
RECRUITINGICU Liver Unit. Hospital Clinic of Barcelona
Barcelona, Catalonia, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
RECRUITINGHospital del Mar
Barcelona, Catalonia, Spain
RECRUITINGHospital Arnau de Vilanova
Lleida, Spain
RECRUITINGCombined: Absence of rebleeding + survival
The primary endpoint combines absence of rebleeding + survival during the first 1 year after inclusion in the study. Patients to compare are those with liver cirrhosis and acute bleeding from IGV1 or GOV2 varices initially treated with combined pharmacological and endoscopic therapy. Those patients will be randomized to receive a TIPS or standard medical therapy (pharmacological + endoscopic injection of tissue adhesives)
Time frame: 1 year
Absence of portal hypertension-related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome)
Comparison of the development of portal-hypertension related complications.
Time frame: 6 weeks and 1 year
Transfusional requirements
We will compare the number of packed red blood cells required by each treatment arms as a surrogate of rebleeding.
Time frame: 6 weeks and 1 year
Individual adverse events
Related and not related to the therapies under study.
Time frame: 1 year
Hospital stay
Including the stay for the index bleed and also readmissions due to complications of liver disease.
Time frame: 1 year
Use of hospital resources
Use of hospital resources other than specified in the treatment arms (TIPS, revision of TIPS patency, derivative surgery or additional endoscopic therapy).
Time frame: 1 year
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