Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Information source: Centre Hospitalier Universitaire de Besancon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cirrhosis
Intervention: liver transplantation (Procedure); standard care for liver disease (Other)
Phase: N/A
Status: Completed
Sponsored by: Centre Hospitalier Universitaire de Besancon Official(s) and/or principal investigator(s):
Jean-Phillipe MIGUET, Study Chair, Affiliation: Service d'Hépatologie - CHU de Besançon
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).
Clinical Details
Official title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: all causes mortality
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
service d'hépatologie CHU jean Minjoz, Besancon 25000, France
Hépato-gastroenterologie CHU Bocage, DIJON 21034, France
Hepato-gastroenterologie, POITIERS 86021, France
CHRU CAEN - Service d'hépato-gastroentérologie, Caen 14033, France
Hôpital Saint-Eloi - Hépato-gastroentérologie, Montpellier 34295, France
Clinique des maladies du foie Hôpital Pontchailloux, Rennes 35000, France
Hôpital Purpan - Hépato-gastroentérologie, Toulouse 31059, France
Hôpital Bon secours - Hépato-gastroentérologie, Metz 57000, France
CHU Reims - hépato-gestroentérologie, Reims 51092, France
Hôpital Pitié-Salpétrière - Hépato-gastroentérologie, Paris 75013, France
Hôpital Beaujon - Hépato-gastroentérologie, Clichy 92110, France
CHU Henri Mondor - Hépato-gastroentérologie, Creteil 94010, France
Centre d'épidémiologie de population EPI 106, Dijon 21079, France
Additional Information
Starting date: March 1994
Ending date: November 2006
Last updated: June 18, 2008
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