TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis

January 22, 2013 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 be checked during the inclusion visit. Informations concerning the trial will also be given. After the investigator receives written informed consent, randomisation will be performed online. Randomisation will be centralized, equilibrated for each center, stratified according to whether cirrhosis is alcoholic or not and adjusted every ten patients.

I Treatments

  1. TIPS :

    TIPS will be performed under sedation or general anesthesia with tracheal intubation according to the usual policy of participating centers. Pre-tips portosystemic pressure gradient and diameter of the shunt must be notified.

    However, for homogeneity reasons the following will be adhered:

    A 10 mm Viator stent will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce portal pressure gradient (PPG) below 12 mmHg. Ideal PPG should be 7-8 mmHg.

  2. Paracentesis + albumin infusion :

After a paracentesis > 3 liters, 8 g of Albumin per liter of extracted ascites must be infused.

If possible, analysis of ascitic fluid will be performed after each paracentesis for biochemical, cytological and bacterial analyses.

II Follow up

  1. In all patients:

    Low salt diet (2 - 4 g/j). Follow up of the patient is as usual. Patients will have a clinical examination at 1 month and then every 3 months up to 1 year. At each visit, clinical and biochemical variables needed to calculate Child-Pugh score will be recorded.

    Doppler ultrasonography will be performed at the beginning, 6 and 12 months. Patients will be followed 1 year or until liver transplantation or death.

    1. Nutritional status evaluation:

      • Weight: M0, M3, M6, M9, M12
      • Anthropometrics measurements: M0, M3, M6, M12: they will include : triceps skinfold thickness, biceps skinfold thickness, brachial circumference.
      • Biochemical parameters: M0, M3, M6, M12: they will include : albumin, pre-albumin, orosomucoïde, C-reactive protein, haptoglobin, natriuresis, 24 hour urinary excretion of creatinine. Four blood samples will be collected and conserved for a posteriori analysis if required (transferrin, retinol binding protein, leptin, hormonal dosages). These analyses will be centralized in Toulouse (Toulouse center will be charged for the shipment of those blood samples).
      • Physical parameters: dual energy x-ray absorptiometry M0, M12
      • Grip test M0, M6, M12 [16, 17].
    2. Quality of Life :

    SF-36 (Short Form 36 (SF-36) Health Survey Questionnaire) at inclusion and then every three months [18, 19].

  2. Paracentesis + albumin infusion group:

    Patients included in this group will be treated by paracentesis whenever required. Eight grams of albumin per liter of ascites extracted will be infused when more than 3 liters of ascitic fluid will be removed.

  3. TIPS group :

When shunt dysfunction will be suspected because of relapse of ascites or incomplete response 2 months after the procedure, an angiography and PPG measurement will be performed. If shunt dysfunction is confirmed, angioplasty or PTFE re-stenting will aim at reducing PPG below 12 mmHg.

III Definition of treatment failure:

After TIPS: relapse of ascites requiring at least 2 paracenteses or persistence after 2 months will be considered as treatment failure. A hemodynamic and angiographic control will be performed. Patients will be treated by refection of the shunt. If severe encephalopathy occurs and persists despite treatment, the diameter of the shunt should be decreased or the TIPS occluded. Total occlusion of the shunt or relapse of ascites after the reduction of its diameter will be also considered treatment failures.

In the group treated by paracentesis + albumin infusion, patients having more than 6 paracenteses within 3 months will be considered for alternative treatment (TIPS, transplantation). Technical impossibility or refusal of the patient to proceed with paracenteses will be also considered treatment failure. In these cases, a TIPS could also be proposed.

All these patients with treatment failure must be followed up to one year after inclusion

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • University Hospital
      • Lille, France, 59000
        • University Hospital
      • Paris, France, 75000
        • Hôpital de la Pitié-Salpêtrière
      • Toulouse, France, 31059
        • Service d'Hépato-Gastro-Entérologie, Hôpital Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival at one year
Time Frame: one year
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Ministry of Health, France
GORE Laboratory

Investigators

  • Principal Investigator: BUREAU Christophe, MD, University Hospital, Toulouse, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0402308
  • PHRC (French Ministry of Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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