Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis (TRANSCIAL)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Cirrhosis

Treatments: Procedure: liver transplantation; Other: standard care for liver disease

Study type: Interventional

Funder types: Other

Identifiers

NCT00701792

N/1993/04

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1

Active Comparator group

Description:

surgery : liver transplantation

Treatment:

Procedure: liver transplantation

2

Active Comparator group

Description:

standard care for liver disease

Treatment:

Other: standard care for liver disease