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

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

June 18, 2008

Start Date ^ICMJE

March 1994

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

all causes mortality [ Time Frame: five years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00701792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cirrhosis

Intervention ^ICMJE

Procedure: liver transplantation
Other: standard care for liver disease

Study Arms / Comparison Groups

Active Comparator: surgery : liver transplantation
Active Comparator: standard care for liver disease

Publications *

Vanlemmens C, Di Martino V, Milan C, Messner M, Minello A, Duvoux C, Poynard T, Perarnau JM, Piquet MA, Pageaux GP, Dharancy S, Silvain C, Hillaire S, Thiefin G, Vinel JP, Hillon P, Collin E, Mantion G, Miguet JP; TRANSCIAL Study Group. Immediate listing for liver transplantation versus standard care for Child-Pugh stage B alcoholic cirrhosis: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):153-61.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00701792

Responsible Party

M. FLAMMARION - Directeur des Projets, de la Recherche CLinique et de l'Innovation, Centre Hospitalier Universitaire de Besancon

Study ID Numbers ^ICMJE

N/1993/04

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Besancon

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Jean-Phillipe MIGUET

Service d'Hépatologie - CHU de Besançon

Information Provided By

Centre Hospitalier Universitaire de Besancon

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP