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

Not Applicable

Recruiting

• Conditions: Liver Cirrhoses
• Interventions: Procedure: TIPS; Procedure: paracentesis

• Registration Number: NCT03172273
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-27
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-06-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-22
• Last Update Posted: 2022-10-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS with PTFE	TIPS	Transjugular Intrahepatic portosystemic shunt with PTFE covered stents
paracentesis	paracentesis	Paracentesis with albumine invision

Primary Outcome Measures

Name	Time	Method
Transplant-free survival	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Xi'an International Medical Center Hospital; 🇨🇳 Xi'an, Shaanxi, China

the First Affiliated Hospital, Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China