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

Study Overview
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Brief Summary
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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 Description
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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).

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

Conditions
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Cirrhosis

Intervention / Treatment
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* Procedure: liver transplantation
* Other: standard care for liver disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>surgery : liver transplantation | Procedure: liver transplantation<br>* liver transplantation<br>|
| Active Comparator: 2<br>standard care for liver disease | Other: standard care for liver disease<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all causes mortality |  | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis transplantation