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

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT00701792
First received: June 5, 2008
Last updated: June 18, 2008
Last verified: June 2008
History of Changes

June 5, 2008
June 18, 2008
March 1994
November 2006   (final data collection date for primary outcome measure)
all causes mortality [ Time Frame: five years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00701792 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
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).

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cirrhosis
  • Procedure: liver transplantation
    liver transplantation
    Other Name: liver transplantation
  • 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".
  • Active Comparator: 1
    surgery : liver transplantation
    Intervention: Procedure: liver transplantation
  • Active Comparator: 2
    standard care for liver disease
    Intervention: Other: standard care for liver disease
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00701792
N/1993/04
No
M. FLAMMARION - Directeur des Projets, de la Recherche CLinique et de l'Innovation, Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire de Besancon
Not Provided
Study Chair: Jean-Phillipe MIGUET Service d'Hépatologie - CHU de Besançon
Centre Hospitalier Universitaire de Besancon
June 2008

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