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TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222014
First Posted: September 22, 2005
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, France
GORE Laboratory
Information provided by (Responsible Party):
University Hospital, Toulouse
  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: None (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:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Survival at one year [ Time Frame: one year ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00222014     History of Changes
Other Study ID Numbers: 0402308
PHRC
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: January 24, 2013
Last Verified: January 2013

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

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