Alcoholic Cirrhosis, Alcoholic Hepatitis
Conditions
Keywords
Alcoholic hepatitis, Liver transplantation, Alcohol relapse, Alcoholic cirrhosis
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.
Interventions
PROCEDURELiver transplantation
Sponsors
Ministry of Health, France
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Group A): * Age \> 18 years * Maddrey score \> 32 * Liver biopsy confirming the diagnosis of alcoholic hepatitis * Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \> 25) despite a low Lille score (\< 0.45) * Hospitalization stay \< 1 month * Algorithm score ≥ 220/250. Inclusion Criteria (Group B): * Age \>18 years * Diagnosis of alcoholic cirrhosis * Alcoholic withdrawal of 6 months minimum before inscription on the transplant list * MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \< 5 cm or 3 nodes \< 3 cm) * MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an expert component * No recommendation of MELD score for patients having obtained an expert component Non-inclusion Criteria (Group A and B): * Bacterial or viral infection uncontrolled by medical treatment * Fungal or aspergillosis uncontrolled infection * Hepatocellular carcinoma or invasive cancer * Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV * Portal thrombosis * Pregnancy or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France
Outcome results
None listed