NCT00222014

Brief Summary

The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

7.6 years

First QC Date

September 13, 2005

Last Update Submit

January 22, 2013

Conditions

Cirrhosis

Keywords

Refractory ascitesCirrhosisParacentesesis

Outcome Measures

Primary Outcomes (1)

  • Survival at one year

    one year

Secondary Outcomes (1)

  • Quality of life, nutritional status, occurrence of complications (other than ascites) secondary to portal hypertension.

    one year

Study Arms (2)

1

EXPERIMENTAL

TIPS réalisé avec prothèse couverte de PTFE

Procedure: TIPS

2

ACTIVE COMPARATOR

Paracenthese and albumine perfusion

Procedure: Paracenthese

Interventions

TIPSPROCEDURE

Transjugular intrahepatic portosystemic shunt with covered PTFE

1
ParacenthesePROCEDURE

Paracenthese

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of both sexes, with cirrhosis, as documented by previous liver-biopsy or usual clinical and biochemical stigmata
  • with refractory or recurrent ascites as defined in chapter IV
  • who signed the informed consent form

You may not qualify if:

  • patients having needed more than 6 paracenteses within the last 3 months
  • patients expected to be transplanted within the next 6 months
  • usual contra-indication for TIPS : congestive heart failure NYHA\>III or medical history of pulmonary hypertension, portal vein thrombosis, hepatic polycystosis, intra-hepatic bile ducts dilatation, spontaneous clinical recurrent hepatic encephalopathy
  • hepatocarcinoma on the expected tract of the shunt
  • severe liver failure as defined by : Prothrombin index \< 35 % or total bilirubin \> 100 micromol/l or Child Pugh Score \>12
  • serum creatinine \> 250 micromol/l
  • uncontrolled sepsis
  • known allergy to albumin
  • pregnant or breast feeding women
  • refusal to participate or patient unable to receive informations or to sign written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital

Angers, 49000, France

Location

University Hospital

Lille, 59000, France

Location

Hôpital de la Pitié-Salpétrière

Paris, 75000, France

Location

Service d'Hépato-Gastro-Entérologie, Hôpital Purpan

Toulouse, 31059, France

Location

Related Publications (3)

  • Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.

    PMID: 14762784BACKGROUND

  • Gonzalez-Garay AG, Serralde-Zuniga AE, Velasco Hidalgo L, Flores Garcia NC, Aguirre-Salgado MI. Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome. Cochrane Database Syst Rev. 2024 Jan 18;1(1):CD011039. doi: 10.1002/14651858.CD011039.pub2.

    PMID: 38235907DERIVED

  • Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20.

    PMID: 27663604DERIVED

MeSH Terms

Conditions

FibrosisAscites

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Study Officials

  • BUREAU Christophe, MD

    University Hospital, Toulouse, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

FR(4)