Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Protocol.
- Who it may be relevant to
- Registry conditions: Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Transplant; Complications. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +22
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs
Overview
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
Detailed description
The aim of this study is to compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT, with patients with decompensated cirrhosis without ACLF-2 or 3 at the time of LT and also with transplant-free survival of patients with ACLF-2 or 3 not listed for LT.
Secondary objectives are as follows:
* To assess the proportion of patients with ACLF-2 or 3 referred to transplant team who are listed or not and reasons of this decision. * To evaluate the outcomes of patients listed with ACLF-2 or 3 on the waiting list compared with those of patients listed with decompensated cirrhosis without ACLF-2 or 3. * To define independent predictive factors of death/delisting on the waiting list for patients listed with ACLF-2 or 3 and develop a new prognostic model based on ACLF criteria to predict mortality on the waiting list and to improve the allocation of organs. * To compare the characteristics of accepted grafts for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3 and their impact on post-LT outcomes. * To explore independent predictive factors of death after LT for patients transplanted with ACLF-2 or 3 to design futility criteria for LT. * To compare post-LT survival rates of patients with ACLF-2 or 3 at listing and patients without ACLF at listing who develop ACLF-2 or 3 on the waiting list. * To compare post-LT quality of life (QoL) for patients listed with ACLF-2 or 3 with those of patients listed with decompensated cirrhosis without ACLF-2 or 3.
Interventions
- Other Observational Protocol
The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
Primary outcome measures
- Survival [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 1\. Male or female subject ≥18 years of age.
2\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
3\. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:
- Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.
- Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD>20) at the time of listing.
- Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.
4\. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United States · 18 centers
- Cedars-Sinai Comprehensive Transplant Center — Los Angeles
- University of Colorado — Aurora
- Tampa General Hospital — Tampa
- Piedmont Healthcare — Atlanta
- Northwestern Memorial Hospital — Chicago
- The University of Chicago Medicine — Chicago
- University of Maryland School of Medicine — Baltimore
- Weill Cornell Medicine — New York
- … and 10 more centers
Germany · 15 centers
- University Hospital Regensburg — Regensburg
- Universitätsklinikum Schleswig-Holstein (UKSH) — Kiel
- University Hospital Aachen — Aachen
- Charité University Hospital — Berlin
- Goethe University Clinic — Frankfurt
- University Medical Center, Hamburg Eppendorf — Hamburg
- Hannover Medical School — Hanover
- University Hospital Heidelberg — Heidelberg
- … and 7 more centers
India · 12 centers
- Aster CMI Hospital — Bengaluru
- Kasturba Hospital — Mumbai
- Seth GSMC & KEM Hospital — Mumbai
- Indraprastha Apollo Hospitals — New Delhi
- Mahatma Gandhi University of Medical Sciences and Technology — Jaipur
- Dr.Rela Institute & Medical Centre — Chennai
- Fortis Hospital Noida, FEHI, FMRI — Gurugramam
- Medanta Medicity — Gurugramam
- … and 4 more centers
France · 9 centers
- APHP Beaujon — Clichy
- APHP Henri Mondor — Créteil
- Hôpital de la Croix-Rousse — Lyon
- CHU Montpellier-Hôpital Saint Eloi — Montpellier
- APHP Hôpitaux Universitaires Pitié Salpêtrière — Paris
- CHU Rennes, Hôpital De Pontchaillou — Rennes
- Hautepièrre Hospital, Service de Réanimation Médicale — Strasbourg
- Trousseau Hospital, — Tours
- … and 1 more center
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Italy · 5 centers
- Ospedale Papa Giovanni XXIII- — Bergamo
- S.Orsola Hospital - Alma Mater Studiorum University of Bologna — Bologna
- Ca' Granda. Policlinico Milano — Milan
- Niguarda Hospital — Milan
- University and Hospital of Padova — Padova
Japan · 5 centers
- Kyushu University Hospital — Fukuoka
- Hiroshima University Hospital — Hiroshima
- Kyoto University Hospital — Kyoto
- … and 2 more centers
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Argentina · 3 centers
- Austral University Hospital — Buenos Aires
- Hospital Alemán — Buenos Aires
- Italian Hospital in Buenos Aires — Buenos Aires
Australia · 3 centers
- Austin Hospital — Heidelberg
- Sir Charles Gairdner Hospital — Nedlands
- Royal Prince Alfred Hospital — Sydney
Belgium · 3 centers
- CUB Erasme Hospital — Brussels
- Ghent University Hospital — Ghent
- UZ Leuven — Leuven
Brazil · 3 centers
- Walter Cantídio University Hospital — Fortaleza
- Irmandade Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
- Hospital das Clínicas da Universidade de São Paulo — São Paulo
Canada · 2 centers
- University of Alberta — Edmonton
- University of Toronto, Multiorgan Transplant Program — Toronto
Netherlands · 2 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Medical University of Vienna, Department of Transplant Surgery — Vienna
Colombia · 1 center
- Pablo Tobón Uribe Hospital — Medellín
Czechia · 1 center
- Institute for Clinical and Experimental Medicine — Prague
Hong Kong · 1 center
- Queen Mary Hospital, The University of Hong Kong — Hong Kong
Mexico · 1 center
Center list to be confirmed — check the primary protocol.
New Zealand · 1 center
Center list to be confirmed — check the primary protocol.
Poland · 1 center
Center list to be confirmed — check the primary protocol.
Portugal · 1 center
Center list to be confirmed — check the primary protocol.
South Korea · 1 center
Center list to be confirmed — check the primary protocol.
Sweden · 1 center
Center list to be confirmed — check the primary protocol.
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Taiwan · 1 center
Center list to be confirmed — check the primary protocol.
Publications
- Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Gines P, Be PMID 25877702
- Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. PMID 28645736
- Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18. PMID 30576643
Identifiers
NCT: NCT04613921 · 2020/01325