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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00088-35 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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
Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver transplantation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
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Inclusion Criteria (Group A):
Inclusion Criteria (Group B):
Non-inclusion Criteria (Group A and B):
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Mathurin, MD,PhD | University hospital of Lille, | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Antwerp | Edegem | B-2650 | Belgium | ||
| ULB, Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35202597 | Result | 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. |
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| 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 | 2 years |
| 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 | 2 years |
| 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. | 2 years |
| Brussels |
| 1070 |
| Belgium |
| Ghent | Belgium |
| Hospital Sart Tilman | Liège | Belgium |
| Univesity hospital | Amiens | 80054 | France |
| University hospital | Angers | 49933 | France |
| University hospital | Besançon | 25030 | France |
| Hôpital Jean Verdier (AH-HP) | Bondy | 93143 | France |
| University hospital | Brest | 29609 | France |
| University hospital | Caen | 14000 | France |
| Univesity hospital | Chambray-lès-Tours | 37170 | France |
| Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris) | Clamart | 92141 | France |
| Hôpital Beaujon (AH-HP) | Clichy | 92118 | France |
| Hôpital Henri Mondor (AP-HP) | Créteil | 94000 | France |
| University hospital | Dijon | 21079 | France |
| University hospital | Grenoble | 38043 | France |
| University hospital | Lille | 59037 | France |
| University hospital | Lyon | 69437 | France |
| University Hospital | Montpellier | 34295 | France |
| University hospital | Nancy | 54500 | France |
| University hospital | Nantes | 44035 | France |
| University hospital | Nice | 06202 | France |
| Hôpital Saint Antoine (AP-HP) | Paris | 75012 | France |
| Hôpital de la Pitié-Salpétrière (AP-HP) | Paris | 75013 | France |
| Hôpital Cochin (AH-HP) | Paris | 75014 | France |
| University Hospital | Pessac | 33604 | France |
| University hospital | Poitiers | 86021 | France |
| University hospital | Reims | 51092 | France |
| University hospital | Rennes | 35033 | France |
| University Hospital | Strasbourg | 67100 | France |
| University hospital | Toulouse | 31059 | France |
| Hôpital Paul Brousse (AH-HP) | Villejuif | 94000 | France |
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D008104 | Liver Cirrhosis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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