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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT00701792

Collaborator

(none)

120

Enrollment

Locations

Arms

152

Duration (Months)

9.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Mar 1, 1994

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

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".

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".

Outcome Measures

Primary Outcome Measures

all causes mortality [five years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	service d'hépatologie CHU jean Minjoz	Besancon	France	25000
2	CHRU CAEN - Service d'hépato-gastroentérologie	Caen	France	14033
3	Hôpital Beaujon - Hépato-gastroentérologie	Clichy	France	92110
4	CHU Henri Mondor - Hépato-gastroentérologie	Creteil	France	94010
5	Hépato-gastroenterologie CHU Bocage	Dijon	France	21034
6	Centre d'épidémiologie de population EPI 106	Dijon	France	21079
7	Hôpital Bon secours - Hépato-gastroentérologie	Metz	France	57000
8	Hôpital Saint-Eloi - Hépato-gastroentérologie	Montpellier	France	34295
9	Hôpital Pitié-Salpétrière - Hépato-gastroentérologie	Paris	France	75013
10	Hepato-gastroenterologie	Poitiers	France	86021
11	CHU Reims - hépato-gestroentérologie	Reims	France	51092
12	Clinique des maladies du foie Hôpital Pontchailloux	Rennes	France	35000
13	Hôpital Purpan - Hépato-gastroentérologie	Toulouse	France	31059