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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-05

Study Completion Date

2019-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcoholic Hepatitis Alcoholic Cirrhosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alcoholic hepatitis Liver transplantation Alcohol relapse Alcoholic cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transplantation of alcoholic hepatitis

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

Group Type OTHER

Liver transplantation

Intervention Type PROCEDURE

Transplantation for alcoholic cirrhosis

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.

Group Type OTHER

Liver transplantation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV
* Portal thrombosis
* Pregnancy or breast-feeding woman

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Mathurin, MD,PhD

Role: STUDY_CHAIR

University hospital of Lille,

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZA

Antwerp, Edegem, Belgium

Site Status

ULB, Erasme

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.

Reference Type RESULT

PMID: 35202597 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-26

Identifier Type: -

Identifier Source: org_study_id

2012-A00088-35

Identifier Type: OTHER

Identifier Source: secondary_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Transplantation of alcoholic hepatitis

Liver transplantation

Transplantation for alcoholic cirrhosis

Liver transplantation

Interventions

Liver transplantation

Eligibility Criteria

Inclusion Criteria

Sponsors

Ministry of Health, France

University Hospital, Lille

Responsible Party

Principal Investigators

Philippe Mathurin, MD,PhD

Locations

UZA

ULB, Erasme

Hospital Sart Tilman

Univesity hospital

University hospital

University hospital

Hôpital Jean Verdier (AH-HP)

University hospital

University hospital

Univesity hospital

Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)

Hôpital Beaujon (AH-HP)

Hôpital Henri Mondor (AP-HP)

University hospital

University hospital

University hospital

University hospital

University Hospital

University hospital

University hospital

University hospital

Hôpital Saint Antoine (AP-HP)

Hôpital de la Pitié-Salpétrière (AP-HP)

Hôpital Cochin (AH-HP)

University Hospital

University hospital

University hospital

University hospital

University Hospital

University hospital

Hôpital Paul Brousse (AH-HP)

Countries

References

Other Identifiers

2010-26

2012-A00088-35