NCT00701792

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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).

Conditions

• Cirrhosis

Interventions

Type	Name	Description
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".

Timeline

• Start date: 1994-03-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-06-19
• Last updated: 2008-06-19

Locations

13 sites across 1 country: France