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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

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 Summary: Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
Sponsor: University Hospital, Lille

Current Primary Outcome: Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome:

  • Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis [ Time Frame: 2 years ]
    First secondary aim is to confirm the survival benefit of patients transplanted for svere 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 [ Time Frame: 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 [ Time Frame: 2 years ]
    Third secondary endpoint is to compare the incidecne 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 [ Time Frame: 2 years ]
    Fourth secondary endopoint 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.


Information By: University Hospital, Lille

Dates:
Date Received: December 20, 2012
Date Started: December 2012
Date Completion: January 2019
Last Updated: January 17, 2017
Last Verified: January 2017