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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Liver Cirrhoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TIPS with PTFE

Transjugular Intrahepatic portosystemic shunt with PTFE covered stents

Group Type EXPERIMENTAL

TIPS

Intervention Type PROCEDURE

Transjugular intrahepatic portosystemic shunt with covered PTFE

paracentesis

Paracentesis with albumine invision

Group Type ACTIVE_COMPARATOR

paracentesis

Intervention Type PROCEDURE

paracentasis plus albumine invision

Interventions

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TIPS

Transjugular intrahepatic portosystemic shunt with covered PTFE

Intervention Type PROCEDURE

paracentesis

paracentasis plus albumine invision

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No