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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

Page last updated: June 20, 2008

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