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TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, France
GORE Laboratory
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00222014
First received: September 13, 2005
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cirrhosis
 Procedure: TIPS
Procedure: Paracenthese

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Survival at one year [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life, nutritional status, occurrence of complications (other than ascites) secondary to portal hypertension. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: May 2005
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TIPS réalisé avec prothèse couverte de PTFE
 Procedure: TIPS
Transjugular intrahepatic portosystemic shunt with covered PTFE
Active Comparator: 2
Paracenthese and albumine perfusion
 Procedure: Paracenthese
Paracenthese

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients not fulfilling inclusion criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222014

Locations
France
University Hospital
Angers, France, 49000
University Hospital
Lille, France, 59000
Hôpital de la Pitié-Salpétrière
Paris, France, 75000
Service d'Hépato-Gastro-Entérologie, Hôpital Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
GORE Laboratory
Investigators
Principal Investigator: BUREAU Christophe, MD University Hospital Toulouse, FRANCE
  More Information

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00222014     History of Changes
Other Study ID Numbers: 0402308, PHRC
Study First Received: September 13, 2005
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Refractory ascites
Cirrhosis
Paracentesesis

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013