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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
  Purpose

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).


Condition Intervention
Cirrhosis
 Procedure: liver transplantation
Other: standard care for liver disease

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • all causes mortality [ Time Frame: five years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 1994
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
surgery : liver transplantation
 Procedure: liver transplantation
liver transplantation
Other Name: 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".

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701792

Locations
France
service d'hépatologie CHU jean Minjoz
Besancon, France, 25000
CHRU CAEN - Service d'hépato-gastroentérologie
Caen, France, 14033
Hôpital Beaujon - Hépato-gastroentérologie
Clichy, France, 92110
CHU Henri Mondor - Hépato-gastroentérologie
Creteil, France, 94010
Hépato-gastroenterologie CHU Bocage
Dijon, France, 21034
Centre d'épidémiologie de population EPI 106
Dijon, France, 21079
Hôpital Bon secours - Hépato-gastroentérologie
Metz, France, 57000
Hôpital Saint-Eloi - Hépato-gastroentérologie
Montpellier, France, 34295
Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
Paris, France, 75013
Hepato-gastroenterologie
Poitiers, France, 86021
CHU Reims - hépato-gestroentérologie
Reims, France, 51092
Clinique des maladies du foie Hôpital Pontchailloux
Rennes, France, 35000
Hôpital Purpan - Hépato-gastroentérologie
Toulouse, France, 31059
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Study Chair: Jean-Phillipe MIGUET Service d'Hépatologie - CHU de Besançon
  More Information

No publications provided by Centre Hospitalier Universitaire de Besancon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M. FLAMMARION - Directeur des Projets, de la Recherche CLinique et de l'Innovation, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT00701792     History of Changes
Other Study ID Numbers: N/1993/04
Study First Received: June 5, 2008
Last Updated: June 18, 2008
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire de Besancon:
cirrhosis transplantation

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
 Alcohol-Related Disorders
Substance-Related Disorders
Liver Extracts
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013