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

Primary Purpose

Alcoholic Hepatitis, Alcoholic Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Liver transplantation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Alcoholic hepatitis, Liver transplantation, Alcohol relapse, Alcoholic cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Transplantation of alcoholic hepatitis

Transplantation for alcoholic cirrhosis

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2012
Last Updated
March 31, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01756794
Brief Title
Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment
Acronym
QuickTrans
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2012 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis, Alcoholic Cirrhosis
Keywords
Alcoholic hepatitis, Liver transplantation, Alcohol relapse, Alcoholic cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transplantation of alcoholic hepatitis
Arm Type
Other
Arm 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
Arm Title
Transplantation for alcoholic cirrhosis
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Liver transplantation
Primary Outcome Measure Information:
Title
Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis
Description
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
Time Frame
2 years
Title
Reproducibility of an algorithm of selection for candidates to liver transplantation
Description
Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers
Time Frame
2 years
Title
Incidence of alcohol relapse
Description
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
Time Frame
2 years
Title
Pattern of alcohol relapse in the two groups of transplanted patients
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Mathurin, MD,PhD
Organizational Affiliation
University hospital of Lille,
Official's Role
Study Chair
Facility Information:
Facility Name
UZA
City
Anvers
State/Province
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
ULB, Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Gent
Country
Belgium
Facility Name
Hospital Sart Tilman
City
Liege
Country
Belgium
Facility Name
Univesity hospital
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
University hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
University hospital
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hôpital Jean Verdier (AH-HP)
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
University hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
University hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Univesity hospital
City
Chambray les tours
ZIP/Postal Code
37170
Country
France
Facility Name
Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hôpital Beaujon (AH-HP)
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hôpital Henri Mondor (AP-HP)
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
University hospital
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
University hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University hospital
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
University hospital
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
University hospital
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
University hospital
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint Antoine (AP-HP)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital de la Pitié-Salpétrière (AP-HP)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin (AH-HP)
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
University Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
University hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
University hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
University hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
University Hospital
City
Strasbourg
ZIP/Postal Code
67100
Country
France
Facility Name
University hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Paul Brousse (AH-HP)
City
Villejuif
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35202597
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.
Results Reference
derived

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

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