Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

Not Applicable

Completed

• Conditions: Alcoholic Cirrhosis; Alcoholic Hepatitis
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT01756794
• Lead Sponsor: University Hospital, Lille

Brief Summary

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

Detailed Description

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

Study Timeline

• Study Start: 2012-12-05
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Primary Completion: 2018-06-07
• Study Completion: 2019-12-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transplantation for alcoholic cirrhosis	Liver transplantation	Patients of this arm will be selected for liver transplantation for alcoholic cirrhosis using an abstinence period of 6 months. Outcome of these patients will be compared to that of patients transplanted for severe alcoholic hepatitis.
Transplantation of alcoholic hepatitis	Liver transplantation	Patients of this arm will be selected for early liver transplantation for severe alcoholic hepatitis not responding to medical therapy. Selection process will be based on a specific algorithm and follow-up time will be 2 years

Primary Outcome Measures

Name	Time	Method
Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.	2 years	Aim is to demonstrate that alcohol relapse within the 2-year follow-up period in patients selected for early liver transplantation for severe alcoholic hepatitis is not inferior to that of patients transplanted for alcoholic cirrhosis using the 6-month sobriety period.

Secondary Outcome Measures

Name	Time	Method
Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis	2 years	First secondary aim is to confirm the survival benefit of patients transplanted for severe alcoholic hepatitis as compared to patients suffering for severe alcoholic hepatitis not responding to medical treatment and not selected for early liver transplantation
Reproducibility of an algorithm of selection for candidates to liver transplantation	2 years	Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers
Incidence of alcohol relapse	2 years	Third secondary endpoint is to compare the incidence of alcohol relapse in patients selected for early transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis using the 6-month sobriety period rule
Pattern of alcohol relapse in the two groups of transplanted patients	2 years	Fourth secondary endpoint is to assess the pattern of alcohol relapse in the group of patients transplanted for severe alcoholic hepatitis to the group of patients transplanted for alcoholic cirrhosis using the 6-month sobriety rule.

Trial Locations

Locations (14)

University hospital; 🇫🇷 Toulouse, France

Hôpital Henri Mondor (AP-HP); 🇫🇷 Créteil, France

Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris); 🇫🇷 Clamart, France

Hôpital Saint Antoine (AP-HP); 🇫🇷 Paris, France

Hôpital de la Pitié-Salpétrière (AP-HP); 🇫🇷 Paris, France

UZA; 🇧🇪 Anvers, Edegem, Belgium

ULB, Erasme; 🇧🇪 Bruxelles, Belgium

Hôpital Jean Verdier (AH-HP); 🇫🇷 Bondy, France

University Hospital; 🇫🇷 Strasbourg, France

Hospital Sart Tilman; 🇧🇪 Liege, Belgium

Hôpital Paul Brousse (AH-HP); 🇫🇷 Villejuif, France

Hôpital Cochin (AH-HP); 🇫🇷 Paris, France

Univesity hospital; 🇫🇷 Chambray les tours, France

Hôpital Beaujon (AH-HP); 🇫🇷 Clichy, France