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

NCT ID: NCT00701792

Last Updated: 2008-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-03-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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

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Cirrhosis

Keywords

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cirrhosis transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

surgery : liver transplantation

Group Type ACTIVE_COMPARATOR

liver transplantation

Intervention Type PROCEDURE

liver transplantation

2

standard care for liver disease

Group Type ACTIVE_COMPARATOR

standard care for liver disease

Intervention Type OTHER

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".

Interventions

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liver transplantation

liver transplantation

Intervention Type PROCEDURE

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".

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Besancon

Principal Investigators

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Jean-Phillipe MIGUET

Role: STUDY_CHAIR

Service d'Hépatologie - CHU de Besançon

Locations

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service d'hépatologie CHU jean Minjoz

Besançon, , France

Site Status

CHRU CAEN - Service d'hépato-gastroentérologie

Caen, , France

Site Status

Hôpital Beaujon - Hépato-gastroentérologie

Clichy, , France

Site Status

CHU Henri Mondor - Hépato-gastroentérologie

Créteil, , France

Site Status

Hépato-gastroenterologie CHU Bocage

Dijon, , France

Site Status

Centre d'épidémiologie de population EPI 106

Dijon, , France

Site Status

Hôpital Bon secours - Hépato-gastroentérologie

Metz, , France

Site Status

Hôpital Saint-Eloi - Hépato-gastroentérologie

Montpellier, , France

Site Status

Hôpital Pitié-Salpétrière - Hépato-gastroentérologie

Paris, , France

Site Status

Hepato-gastroenterologie

Poitiers, , France

Site Status

CHU Reims - hépato-gestroentérologie

Reims, , France

Site Status

Clinique des maladies du foie Hôpital Pontchailloux

Rennes, , France

Site Status

Hôpital Purpan - Hépato-gastroentérologie

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 19189904 (View on PubMed)

Other Identifiers

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N/1993/04

Identifier Type: -

Identifier Source: org_study_id