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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT03172273

Collaborator

(none)

180

Enrollment

Location

Arms

62.7

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses	Procedure: TIPS Procedure: paracentesis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 29, 2017

Anticipated Primary Completion Date :

Sep 18, 2022

Anticipated Study Completion Date :

Sep 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIPS with PTFE Transjugular Intrahepatic portosystemic shunt with PTFE covered stents	Procedure: TIPS Transjugular intrahepatic portosystemic shunt with covered PTFE
Active Comparator: paracentesis Paracentesis with albumine invision	Procedure: paracentesis paracentasis plus albumine invision

Arm

Intervention/Treatment

Experimental: TIPS with PTFE

Transjugular Intrahepatic portosystemic shunt with PTFE covered stents

Procedure: TIPS

Transjugular intrahepatic portosystemic shunt with covered PTFE

Active Comparator: paracentesis

Paracentesis with albumine invision

Procedure: paracentesis

paracentasis plus albumine invision

Outcome Measures

Primary Outcome Measures

Transplant-free survival [12 months]

Secondary Outcome Measures

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]
Quality of life [12 months]
Other Liver Disease Complications (Adverse Events) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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