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

June 18, 2008 updated by: Centre Hospitalier Universitaire de Besancon

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • service d'hépatologie CHU jean Minjoz
      • Caen, France, 14033
        • CHRU CAEN - Service d'hépato-gastroentérologie
      • Clichy, France, 92110
        • Hôpital Beaujon - Hépato-gastroentérologie
      • Creteil, France, 94010
        • CHU Henri Mondor - Hépato-gastroentérologie
      • Dijon, France, 21034
        • Hépato-gastroenterologie CHU Bocage
      • Dijon, France, 21079
        • Centre d'épidémiologie de population EPI 106
      • Metz, France, 57000
        • Hôpital Bon secours - Hépato-gastroentérologie
      • Montpellier, France, 34295
        • Hôpital Saint-Eloi - Hépato-gastroentérologie
      • Paris, France, 75013
        • Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
      • Poitiers, France, 86021
        • Hepato-gastroenterologie
      • Reims, France, 51092
        • CHU Reims - hépato-gestroentérologie
      • Rennes, France, 35000
        • Clinique des maladies du foie Hôpital Pontchailloux
      • Toulouse, France, 31059
        • Hôpital Purpan - Hépato-gastroentérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
surgery : liver transplantation
Procedure: liver transplantation
liver transplantation
Active Comparator: 2
standard care for liver disease
Other: standard care for liver disease
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all causes mortality
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Chair: Jean-Phillipe MIGUET, Service d'Hépatologie - CHU de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1994

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

June 19, 2008

Last Update Submitted That Met QC Criteria

June 18, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/1993/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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