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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Procedure: TIPS
* Procedure: paracentesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPS with PTFE<br>Transjugular Intrahepatic portosystemic shunt with PTFE covered stents | Procedure: TIPS<br>* Transjugular intrahepatic portosystemic shunt with covered PTFE<br>|
| Active Comparator: paracentesis<br>Paracentesis with albumine invision | Procedure: paracentesis<br>* paracentasis plus albumine invision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant-free survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of paracentesis |  | 12 months | 
| Frequency of overt Hepatic Encephalopathy | Number of episodes of West Haven grade 2 or greater without precipitating factor | 12 months | 
| Nutritional status |  | 12 months | 
| Quality of life |  | 12 months | 
| Other Liver Disease Complications (Adverse Events) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites