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

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Procedure: liver transplantation; Other: standard care for liver disease

• Registration Number: NCT00701792
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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 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).

Study Timeline

• Study Start: 1994-03
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-18
• Last Update Submitted: 2008-06-18
• Study First Posted: 2008-06-19
• Last Update Posted: 2008-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	liver transplantation	surgery : liver transplantation
2	standard care for liver disease	standard care for liver disease

Primary Outcome Measures

Name	Time	Method
all causes mortality	five years

Trial Locations

Locations (13)

service d'hépatologie CHU jean Minjoz; 🇫🇷 Besancon, France

CHRU CAEN - Service d'hépato-gastroentérologie; 🇫🇷 Caen, France

Hépato-gastroenterologie CHU Bocage; 🇫🇷 Dijon, France

Centre d'épidémiologie de population EPI 106; 🇫🇷 Dijon, France

Hôpital Bon secours - Hépato-gastroentérologie; 🇫🇷 Metz, France

Hepato-gastroenterologie; 🇫🇷 Poitiers, France

CHU Reims - hépato-gestroentérologie; 🇫🇷 Reims, France

Clinique des maladies du foie Hôpital Pontchailloux; 🇫🇷 Rennes, France

Hôpital Pitié-Salpétrière - Hépato-gastroentérologie; 🇫🇷 Paris, France

Hôpital Purpan - Hépato-gastroentérologie; 🇫🇷 Toulouse, France

CHU Henri Mondor - Hépato-gastroentérologie; 🇫🇷 Creteil, France

Hôpital Beaujon - Hépato-gastroentérologie; 🇫🇷 Clichy, France

Hôpital Saint-Eloi - Hépato-gastroentérologie; 🇫🇷 Montpellier, France