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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Liver Cirrhoses

Treatments: Procedure: paracentesis; Procedure: TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT03172273

RA-TIPS

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

TIPS with PTFE

Experimental group

Description:

Transjugular Intrahepatic portosystemic shunt with PTFE covered stents

Treatment:

Procedure: TIPS

paracentesis

Active Comparator group

Description:

Paracentesis with albumine invision

Treatment:

Procedure: paracentesis