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

NCT01756794 | Completed

• 2 other identifiers: 2010-262012-A00088-35
• Study Type: interventional
• Target: 284
• Locations: 2 countries
• Sites: 32

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

Conditions

Alcoholic Hepatitis; Alcoholic Cirrhosis

Keywords

Alcoholic hepatitis; Liver transplantation; Alcohol relapse; Alcoholic cirrhosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 years

Secondary Outcomes (4)

• Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis

  2 years

• Reproducibility of an algorithm of selection for candidates to liver transplantation

  2 years

• Incidence of alcohol relapse

  2 years

• Pattern of alcohol relapse in the two groups of transplanted patients

  2 years

Study Arms (2)

Transplantation of alcoholic hepatitis

OTHER

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

Procedure: Liver transplantation

Transplantation for alcoholic cirrhosis

OTHER

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.

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Transplantation for alcoholic cirrhosis; Transplantation of alcoholic hepatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Bacterial or viral infection uncontrolled by medical treatment
• Fungal or aspergillosis uncontrolled infection
• Hepatocellular carcinoma or invasive cancer

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (32)

UZA

Antwerp, Edegem, B-2650, Belgium

Location

ULB, Erasme

Brussels, 1070, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Hospital Sart Tilman

Liège, Belgium

Location

Univesity hospital

Amiens, 80054, France

Location

University hospital

Angers, 49933, France

Location

University hospital

Besançon, 25030, France

Location

Hôpital Jean Verdier (AH-HP)

Bondy, 93143, France

Location

University hospital

Brest, 29609, France

Location

University hospital

Caen, 14000, France

Location

Univesity hospital

Chambray-lès-Tours, 37170, France

Location

Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)

Clamart, 92141, France

Location

Hôpital Beaujon (AH-HP)

Clichy, 92118, France

Location

Hôpital Henri Mondor (AP-HP)

Créteil, 94000, France

Location

University hospital

Dijon, 21079, France

Location

University hospital

Grenoble, 38043, France

Location

University hospital

Lille, 59037, France

Location

University hospital

Lyon, 69437, France

Location

University Hospital

Montpellier, 34295, France

Location

University hospital

Nancy, 54500, France

Location

University hospital

Nantes, 44035, France

Location

University hospital

Nice, 06202, France

Location

Hôpital Saint Antoine (AP-HP)

Paris, 75012, France

Location

Hôpital de la Pitié-Salpétrière (AP-HP)

Paris, 75013, France

Location

Hôpital Cochin (AH-HP)

Paris, 75014, France

Location

University Hospital

Pessac, 33604, France

Location

University hospital

Poitiers, 86021, France

Location

University hospital

Reims, 51092, France

Location

University hospital

Rennes, 35033, France

Location

University Hospital

Strasbourg, 67100, France

Location

University hospital

Toulouse, 31059, France

Location

Hôpital Paul Brousse (AH-HP)

Villejuif, 94000, France

Location

Related Publications (1)

• 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.

  PMID: 35202597 RESULT

MeSH Terms

Conditions

Hepatitis, Alcoholic; Liver Cirrhosis, Alcoholic

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Philippe Mathurin, MD,PhD

  University hospital of Lille,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: December 5, 2012
• Primary Completion: June 7, 2018
• Study Completion: December 5, 2019
• Last Updated: December 22, 2025

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); FR (28)