Official Title: “Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis”

Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2006

120 patients (60 per group) were included. The therapeutic strategy defined by randomization was achieved in 68% of group 1 patients and 75% of group 2 patients (NS). All-causes death and cirrhosis-related death were not different in group 1 and group 2 patients: the five-year survival rate was 58% in group 1 and 69% in group 2 patients (NS). Through multivariate analysis, the independent predictors of long-term survival were absence of ongoing alcohol consumption (p<0.001), recovery from Pugh C (p=0.046), and baseline Pugh score<8 (p=0.029).

Liver transplantation was associated with a higher rate of de novo malignancies (30.4% vs.

7.8%, OR=5.1, p=0.001).

Intervention(s) in this Clinical Trial

• Procedure: liver transplantation
  • liver transplantation
• Other: standard care for liver disease
  • standard care for liver disease included therapy for ascitis (spironolactone, furosemide), portal hypertension (oesophageal varices ; propranolol), encephalopathy (lactulose), and bacterial infections whatever their localization (prophylaxis of spontaneous peritonitis with norfloxacin). All medical or instrumental procedures were allowed. Patients undergoing iterative paracentesis, variceal band ligation or sclerotherapy, peritoneojugular shunt (LeVeen), transjugular intrahepatic portosystemic shunt (TIPS) or surgical portocaval anastomosis were considered as receiving "standard medical therapy".

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • surgery : liver transplantation
• Active Comparator: 2
  • standard care for liver disease

Primary Measures

• all causes mortality
  • Time Frame: five years
    Safety Issue?: No

Inclusion Criteria:

• cirrhosis
• age 18-65yrs
• Pugh B
• written consent

Exclusion Criteria:

• HIV, HBV or HCV infection
• hepatocellular carcinoma
• Pugh A or Pugh C cirrhosis
• creatinin >200µMol/L
• sepsis
• psychiatric disorders
• extrahepatic neoplasia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Overall Clinical Trial Officials and Contacts

Jean-Phillipe MIGUET Study Chair Service d'Hépatologie - CHU de Besançon  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701792

Study ID Number: N/1993/04

ClinicalTrials.gov Identifier: NCT00701792

Health Authority: France: Direction Générale de la Santé