Clinical trial NCT01756794: Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment
Official title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Hepatitis
Alcoholic Cirrhosis
Keywords: Alcoholic hepatitis
Liver transplantation
Alcohol relapse
Alcoholic cirrhosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-12-27
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
timeFrame: 2 years
Secondary outcomes:
measure: Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis
timeFrame: 2 years
measure: Reproducibility of an algorithm of selection for candidates to liver transplantation
timeFrame: 2 years
measure: Incidence of alcohol relapse
timeFrame: 2 years
measure: Pattern of alcohol relapse in the two groups of transplanted patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Anvers
country: Belgium
facility: UZA
state: Edegem
city: Bruxelles
country: Belgium
facility: ULB, Erasme
city: Gent
country: Belgium
city: Liege
country: Belgium
facility: Hospital Sart Tilman
city: Amiens
country: France
facility: Univesity hospital
city: Angers
country: France
facility: University hospital
city: Besançon
country: France
facility: University hospital
city: Bondy
country: France
facility: Hôpital Jean Verdier (AH-HP)
city: Brest
country: France
facility: University hospital
city: Caen
country: France
facility: University hospital
city: Chambray les tours
country: France
facility: Univesity hospital
city: Clamart
country: France
facility: Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)
city: Clichy
country: France
facility: Hôpital Beaujon (AH-HP)
city: Créteil
country: France
facility: Hôpital Henri Mondor (AP-HP)
city: Dijon
country: France
facility: University hospital
city: Grenoble
country: France
facility: University hospital
city: Lille
country: France
facility: University hospital
city: Lyon
country: France
facility: University hospital
city: Montpellier
country: France
facility: University Hospital
city: Nancy
country: France
facility: University hospital
city: Nantes
country: France
facility: University hospital
city: Nice
country: France
facility: University hospital
city: Paris
country: France
facility: Hôpital Saint Antoine (AP-HP)
city: Paris
country: France
facility: Hôpital de la Pitié-Salpétrière (AP-HP)
city: Paris
country: France
facility: Hôpital Cochin (AH-HP)
city: Pessac
country: France
facility: University Hospital
city: Poitiers
country: France
facility: University hospital
city: Reims
country: France
facility: University hospital
city: Rennes
country: France
facility: University hospital
city: Strasbourg
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University hospital
city: Villejuif
country: France
facility: Hôpital Paul Brousse (AH-HP)
Study officials:
affiliation: University hospital of Lille,
name: Philippe Mathurin, MD,PhD
role: STUDY_CHAIR
References:
citation: Louvet A, Labreuche J, Moreno C, Vanlemmens C, Moirand R, Feray C, Dumortier J, Pageaux GP, Bureau C, Chermak F, Duvoux C, Thabut D, Leroy V, Carbonell N, Rolland B, Salame E, Anty R, Gournay J, Delwaide J, Silvain C, Lucidi V, Lassailly G, Dharancy S, Nguyen-Khac E, Samuel D, Duhamel A, Mathurin P; QuickTrans trial study group. Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study. Lancet Gastroenterol Hepatol. 2022 May;7(5):416-425. doi: 10.1016/S2468-1253(21)00430-1. Epub 2022 Feb 23.