Liver Transplantation in Alcoholic Hepatitis (SETH-HA)
|ClinicalTrials.gov Identifier: NCT01768715|
Recruitment Status : Suspended (Low rate of recruitment (only one patient up to May 2014))
First Posted : January 15, 2013
Last Update Posted : June 3, 2014
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.
|Condition or disease|
This is a open prospective multicenter study. Nineteen liver transplant units in Spain will take part in it.
Inclusion criteria for patients:
- Diagnosis of alcoholic hepatitis (liver biopsy will be advisable).
- First episode of clinical decompensation of alcoholic liver disease (defined as jaundice, variceal bleeding, ascites or portal-systemic encephalopathy).
- Absence of a high risk of alcoholic recidivism (according to De Gottardi, et al).
- Severe alcoholic hepatitis (ABIC score > 6.71)
- Informed consent
Exclusion criteria :
- Age over 65 years.
- Hepatitis B or C or HIV infections.
- Uncontrolled bacterial infection
- Other liver diseases, such as alpha-1-antitrypsin deficiency, primary biliary cirrhosis, ...
- Morbid obesity (BMI > 35 kg/m2)
- Major uncontrolled psychiatric disease
- Drug addiction (excluding tobacco) in the last two years.
- Absence of informed consent.
- Acute-on-chronic liver disease.
- Paracetamol consumption over 10 grams in the last week.
Criteria for liver transplantation.
- Absence of response to steroid therapy (Lille score ≥ 0.45 7 days after initiation of steroid therapy).
- Adequate social and familiar environment.
- Complete agreement in the medical staff about the candidate to transplantation.
- Absence of bacterial or fungal infection.
Three groups of patients will be formed:
Group 1. Patients with severe alcoholic hepatitis and good response to therapy. Group 2. Patients with severe alcoholic hepatitis and poor response to therapy, that are not candidates to transplantation.
Group 3. Patients with severe alcoholic hepatitis and poor response to therapy, that are candidates to transplantation.
A complete follow-up of the patients would be extended to five years. The survival of these three groups will be compared. Survival of liver transplant recipients should also be compared with survival of other liver transplant recipients.
Alcohol recidivism should also be studied in all the patients of the study. Sample size estimation: According to the data published by Mathurin et al, 28 patients treated with liver transplantation and 28 non-transplanted patients with severe alcoholic hepatitis should be necessary.
Interim analysis after every 10 transplanted patients should be performed. The study will be interrupted if the differences in the survivals between groups 2 and 3 reaches a significance of 0.01. In case this significance is not reached the inclusion of patients should end when 40 patients are transplanted. This sample size is estimated to be reached in 18-24 months.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Applicability of Liver Transplantation in Alcoholic Hepatitis|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2017|
Patients with severe alcoholic hepatitis and good response to therapy.
Non transplant candidates
Patients with severe alcoholic hepatitis and poor response to therapy, that are not candidates to transplantation, according to the specified criteria.
Patients with severe alcoholic hepatitis and poor response to therapy, that are candidates to transplantation, according to the specified criteria.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768715
|Hospital Central de Asturias|
|Oviedo, Asturias, Spain|
|Hospital Marqués de Valdecilla|
|Santander, Cantabria, Spain|
|Hospital Clínico Universitario de Santiago|
|Santiago de Compostela, La Coruña, Spain|
|Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain|
|Clínica Universidad de Navarra|
|Pamplona, Navarra, Spain|
|Hospital Vall d'Hebrón|
|Hospital Reina Sofía|
|Hospital Virgen de la Nieves|
|Complejo Hospitalario Universitario de la Coruña|
|La Coruña, Spain|
|Hospital Gregorio Marañón|
|Hospital Ramón y Cajal|
|Hospital Virgen de la Arrixaca|
|Hospital Carlos Haya|
|Hospital Virgen del Rocío|
|Hospital La Fe|
|Hospital Río Hortega|
|Hospital Lozano Blesa|
|Study Chair:||Ignacio Herrero, MD||Clinica Universidad de Navarra|
|Study Chair:||Santiago Tome, MD||Complejo Hospitalario Universitario de Santiago|
|Study Chair:||Ignacio Gonzalez-Pinto, MD||Hospital Central de Asturias|