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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701792
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : June 19, 2008
Information provided by:
Centre Hospitalier Universitaire de Besancon

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).

Condition or disease Intervention/treatment Phase
Cirrhosis Procedure: liver transplantation Other: standard care for liver disease Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Study Start Date : March 1994
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

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".

Primary Outcome Measures :
  1. all causes mortality [ Time Frame: five years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701792

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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
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
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Study Chair: Jean-Phillipe MIGUET Service d'Hépatologie - CHU de Besançon
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M. FLAMMARION - Directeur des Projets, de la Recherche CLinique et de l'Innovation, Centre Hospitalier Universitaire de Besancon Identifier: NCT00701792    
Other Study ID Numbers: N/1993/04
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: June 19, 2008
Last Verified: June 2008
Keywords provided by Centre Hospitalier Universitaire de Besancon:
cirrhosis transplantation
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Alcoholic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Liver Extracts