Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) in Patients With Liver Cirrhosis and Ascites: a Multicentre, Randomised Controlled Trial

What this Trial Is About

This clinical trial evaluates the safety and effectiveness of early transjugular intrahepatic portosystemic shunt (TIPS) implantation compared to standard treatment in patients with liver cirrhosis who develop ascites as their first decompensating event. The study focuses on reducing portal vein pressure by creating a shunt between the liver vein and portal vein, aiming to control ascites and improve clinical outcomes. Liver cirrhosis complications mainly arise from portal hypertension, and TIPS has been recommended for variceal bleeding and advanced ascites stages. This trial explores early TIPS use in ascites management. Participants are randomly assigned to one of two groups: one receiving early TIPS implantation when ascites reaches grade 2 with MELD ≥ 15 or grade 3 ascites; the other receiving standard medical treatment based on current guidelines, including salt restriction, diuretics, carvedilol, large-volume paracentesis if needed, and albumin substitution when over 5 liters of ascites are removed. TIPS implantation involves creating a shunt to reduce portal pressure, while the control group receives conventional medication and paracentesis as necessary. Participants are monitored over an average of 12 months for transplantation-free survival as the primary outcome. Secondary outcomes include time until ascites requires paracentesis, quality of life assessments at baseline, 6, and 12 months, the rate of TIPS implantation in the standard treatment group, and TIPS dysfunction rates. The study involves regular clinical evaluations and follows up on safety and efficacy throughout the year-long observation period.

Early TIPS in Patients With Liver Cirrhosis and Ascites