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

University Hospital, Lille

Status: Completed

Conditions: Alcoholic Cirrhosis; Alcoholic Hepatitis

Treatments: Procedure: Liver transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01756794

2012-A00088-35 (Other Identifier)

2010-26

Details and patient eligibility

About

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

Full description

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

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Transplantation of alcoholic hepatitis

Other group

Description:

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

Treatment:

Procedure: Liver transplantation

Transplantation for alcoholic cirrhosis

Other group

Description:

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.

Treatment:

Procedure: Liver transplantation