TIPS With Coated Stents for Refractory Ascites in Patients With Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional

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 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
    

Intervention name(s): TIPS; Paracenthese
Intervention type(s): Procedure; Procedure
Intervention description(s): Transjugular intrahepatic portosystemic shunt with covered PTFE; Paracenthese
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory ascites; Cirrhosis; Paracentesesis