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

Sponsored by:	Centre Hospitalier Universitaire de Besancon
Information provided by:	Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:	NCT00701792

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:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Liver Diseases Liver Transplantation

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
1: Active Comparator surgery : liver transplantation	Procedure: liver transplantation liver transplantation
2: Active Comparator 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".

Arms

Assigned Interventions

1: Active Comparator

surgery : liver transplantation

Procedure: liver transplantation

liver transplantation

2: Active Comparator

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
Hépato-gastroenterologie CHU Bocage
DIJON, France, 21034
Hepato-gastroenterologie
POITIERS, France, 86021
CHRU CAEN - Service d'hépato-gastroentérologie
Caen, France, 14033
Hôpital Saint-Eloi - Hépato-gastroentérologie
Montpellier, France, 34295
Clinique des maladies du foie Hôpital Pontchailloux
Rennes, France, 35000
Centre d'épidémiologie de population EPI 106
Dijon, France, 21079
Hôpital Bon secours - Hépato-gastroentérologie
Metz, France, 57000
CHU Reims - hépato-gestroentérologie
Reims, France, 51092
Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
Paris, France, 75013
Hôpital Beaujon - Hépato-gastroentérologie
Clichy, France, 92110
CHU Henri Mondor - Hépato-gastroentérologie
Creteil, France, 94010
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 National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Centre Hospitalier Universitaire de Besancon:

cirrhosis transplantation

Study placed in the following topic categories:

Alcohol-Induced Disorders
Liver Diseases
Norfloxacin
Fibrosis
Disorders of Environmental Origin
Liver Cirrhosis
Furosemide
Spironolactone

Liver Diseases, Alcoholic
Digestive System Diseases
Propranolol
Substance-Related Disorders
Alcohol-Related Disorders
Liver Cirrhosis, Alcoholic
Lactulose

Additional relevant MeSH terms:

Alcohol-Induced Disorders
Liver Diseases, Alcoholic
Liver Diseases
Pathologic Processes
Digestive System Diseases
Fibrosis

Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Liver Cirrhosis
Liver Cirrhosis, Alcoholic

ClinicalTrials.gov processed this record on July 02, 2009