Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites

Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites

This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.

Inclusion Criteria:

• Confirmed diagnosis of liver cirrhosis
• Recurrent and refractory ascites
• Patients with an age between 18 and 65 years old
• Child-Pugh ≤12
• Absence of hepatic encephalopathy
• Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
• Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study

Exclusion Criteria:

• With more than 6 paracenteses within the last 3 months
• patients expected to receive transplants within the next 6 months or on waiting list
• Usual contra-indication for TIPS: congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis（>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation
• Patient has had previous TIPS placement
• Severe liver dysfunction by: Prothrombin index < 40% or total bilirubin > 50μmol/l
• Serum creatinine >133μmol/l
• Severe hyponatremia <125mmol / L
• Uncontrolled sepsis
• Gastrointestinal hemorrhage within 6 weeks of randomization
• Known allergy to albumin
• Pregnant or breast feeding women
• Refusal to participate or patient unable to receive informations or to sign written informed consent