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

Cirrhosis Clinical Trial

— TRANSCIAL  

Official title:

Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701792
• Other study ID #: N/1993/04
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: June 18, 2008
• Start date: March 1994
• Est. completion date: November 2006

Study information

• Verified date: June 2008
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Procedure:
• liver transplantation
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".

Locations

Country	Name	City	State
France	service d'hépatologie CHU jean Minjoz	Besancon
France	CHRU CAEN - Service d'hépato-gastroentérologie	Caen
France	Hôpital Beaujon - Hépato-gastroentérologie	Clichy
France	CHU Henri Mondor - Hépato-gastroentérologie	Creteil
France	Centre d'épidémiologie de population EPI 106	Dijon
France	Hépato-gastroenterologie CHU Bocage	Dijon
France	Hôpital Bon secours - Hépato-gastroentérologie	Metz
France	Hôpital Saint-Eloi - Hépato-gastroentérologie	Montpellier
France	Hôpital Pitié-Salpétrière - Hépato-gastroentérologie	Paris
France	Hepato-gastroenterologie	Poitiers
France	CHU Reims - hépato-gestroentérologie	Reims
France	Clinique des maladies du foie Hôpital Pontchailloux	Rennes
France	Hôpital Purpan - Hépato-gastroentérologie	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all causes mortality		five years	No