Clinical Trial: Liver Transplantation in Alcoholic Hepatitis

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: Applicability of Liver Transplantation in Alcoholic Hepatitis

Brief Summary:

Patients with alcoholic hepatitis non-responsive to steroids have a poor prognosis. Recently a French-Belgian prospective study has obtained good results (acceptable survival with a low rate of alcohol recidivism).

The hypothesis of the present study is that carefully selected Spanish patients with alcoholic hepatitis that do not respond to steroid therapy may have a good survival if they receive a liver transplant. The expected rate of alcohol recidivism in such a selected population will be low.


Detailed Summary:

This is a open prospective multicenter study. Nineteen liver transplant units in Spain will take part in it.

Inclusion criteria for patients:

  1. Diagnosis of alcoholic hepatitis (liver biopsy will be advisable).
  2. First episode of clinical decompensation of alcoholic liver disease (defined as jaundice, variceal bleeding, ascites or portal-systemic encephalopathy).
  3. Absence of a high risk of alcoholic recidivism (according to De Gottardi, et al).
  4. Severe alcoholic hepatitis (ABIC score > 6.71)
  5. Informed consent

Exclusion criteria :

  1. Age over 65 years.
  2. Hepatitis B or C or HIV infections.
  3. Uncontrolled bacterial infection
  4. Other liver diseases, such as alpha-1-antitrypsin deficiency, primary biliary cirrhosis, ...
  5. Morbid obesity (BMI > 35 kg/m2)
  6. Major uncontrolled psychiatric disease
  7. Drug addiction (excluding tobacco) in the last two years.
  8. Absence of informed consent.
  9. Acute-on-chronic liver disease.
  10. Paracetamol consumption over 10 grams in the last week.

Criteria for liver transplantation.

  1. Absence of response to steroid therapy (Lille score ≥ 0.45 7 days after initiation of
    Sponsor: Sociedad Española de Trasplante Hepático

    Current Primary Outcome: Evaluate survival of patients with severe alcoholic hepatitis non responsive to therapy after liver transplantation [ Time Frame: 1 year after the diagnosis of alcoholic hepatitis ]

    The survival of patients transplanted with alcoholic hepatitis is going to be compared with the survival of patients with alcoholic hepatitis that are not considered adequate for liver transplantation


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Evaluate the applicability of liver transplantation in patients with alcoholic hepatitis non responsive to steroid therapy [ Time Frame: 1 year ]
      The applicability of liver transplantation is defined as the ratio between the number of patients transplanted for alcoholic hepatitis and the number of patients with severe alcoholic hepatitis that do not respond to steroid therapy.
    • Evaluate the mortality in waiting list for transplantation of patients with alcoholic hepatitis unresponsive to steroid therapy [ Time Frame: 1 year ]
      Proportion of patients who are accepted as candidates for liver transplantation who die before transplantation.
    • Evaluate the rate of alcohol recidivism after liver transplantation for alcoholic hepatitis [ Time Frame: 1, 2, 3, 4 and 5 years ]
      Proportion of patients transplanted for alcoholic hepatitis that have a recurrence in alcohol consumption
    • Evaluate survival of patients with alcoholic hepatitis after liver transplantation. [ Time Frame: 2, 3, 4 and 5 years after the diagnosis of alcoholic hepatitis ]
      The survival of patients transplanted with alcoholic hepatitis is going to be compared with the survival of patients with alcoholic hepatitis that are not considered adequate for liver transplantation


    Original Secondary Outcome: Same as current

    Information By: Sociedad Española de Trasplante Hepático

    Dates:
    Date Received: December 29, 2012
    Date Started: January 2013
    Date Completion: December 2017
    Last Updated: June 2, 2014
    Last Verified: June 2014