Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment (QuickTrans)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01756794 |
|
Recruitment Status :
Completed
First Posted : December 27, 2012
Last Update Posted : April 2, 2020
|
Sponsor:
University Hospital, Lille
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcoholic Hepatitis Alcoholic Cirrhosis | Procedure: Liver transplantation | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 284 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA. |
| Actual Study Start Date : | December 5, 2012 |
| Actual Primary Completion Date : | June 7, 2018 |
| Actual Study Completion Date : | December 5, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
North American Indian childhood cirrhosis
| Arm | Intervention/treatment |
|---|---|
|
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
|
Procedure: Liver transplantation |
|
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.
|
Procedure: Liver transplantation |
Primary Outcome Measures :
- Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis. [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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 [ Time Frame: 2 years ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756794
Locations
Show 32 study locations
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
| Study Chair: | Philippe Mathurin, MD,PhD | University hospital of Lille, |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01756794 |
| Other Study ID Numbers: |
2010-26 2012-A00088-35 ( Other Identifier: ID-RCB number, ANSM ) |
| First Posted: | December 27, 2012 Key Record Dates |
| Last Update Posted: | April 2, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University Hospital, Lille:
|
Alcoholic hepatitis Liver transplantation Alcohol relapse Alcoholic cirrhosis |
Additional relevant MeSH terms:
|
Hepatitis A Hepatitis Hepatitis, Alcoholic Liver Cirrhosis, Alcoholic Fibrosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Pathologic Processes Liver Cirrhosis Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |