Clinical trial NCT00701792: Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Official title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: cirrhosis transplantation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: all causes mortality
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: service d'hépatologie CHU jean Minjoz
city: Caen
country: France
facility: CHRU CAEN - Service d'hépato-gastroentérologie
city: Clichy
country: France
facility: Hôpital Beaujon - Hépato-gastroentérologie
city: Creteil
country: France
facility: CHU Henri Mondor - Hépato-gastroentérologie
city: Dijon
country: France
facility: Hépato-gastroenterologie CHU Bocage
city: Dijon
country: France
facility: Centre d'épidémiologie de population EPI 106
city: Metz
country: France
facility: Hôpital Bon secours - Hépato-gastroentérologie
city: Montpellier
country: France
facility: Hôpital Saint-Eloi - Hépato-gastroentérologie
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière - Hépato-gastroentérologie
city: Poitiers
country: France
facility: Hepato-gastroenterologie
city: Reims
country: France
facility: CHU Reims - hépato-gestroentérologie
city: Rennes
country: France
facility: Clinique des maladies du foie Hôpital Pontchailloux
city: Toulouse
country: France
facility: Hôpital Purpan - Hépato-gastroentérologie
Study officials:
affiliation: Service d'Hépatologie - CHU de Besançon
name: Jean-Phillipe MIGUET
role: STUDY_CHAIR
References:
citation: 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. doi: 10.7326/0003-4819-150-3-200902030-00004.