Status:
COMPLETED
TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Ministry of Health, France
GORE Laboratory
Conditions:
Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Detailed Description
Diagnostic evaluation before randomisation includes assessment of clinical hepatic encephalopathy, usual blood tests, and Doppler-ultrasonography of the abdomen. Inclusion and exclusion criteria will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00222014
Start Date
May 1 2005
End Date
January 1 2013
Last Update
January 24 2013
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Angers, France, 49000
2
University Hospital
Lille, France, 59000
3
Hôpital de la Pitié-Salpétrière
Paris, France, 75000
4
Service d'Hépato-Gastro-Entérologie, Hôpital Purpan
Toulouse, France, 31059