Clinical Trial: Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary: 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).
Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: all causes mortality [ Time Frame: five years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: June 5, 2008
Date Started: March 1994
Date Completion:
Last Updated: June 18, 2008
Last Verified: June 2008