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| Name | Class |
|---|---|
| University of Roma La Sapienza | OTHER |
| University of Pisa | OTHER |
| A.O.U. Città della Salute e della Scienza | OTHER |
| Niguarda Hospital |
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In Italy, since August 2014, liver transplantation (LT) candidates with MELD≥30 receive a priority allocation consenting them to access in an organ sharing macroarea. The primary intent of this policy is to minimize the higher risk of waiting list dropout observed in these patients. Another objective of this allocation strategy is to reduce the waiting time, thus performing the LT in better clinical conditions. This multicentre retrospective national study aims to evaluate several parameters of efficacy and equity, such as waiting time in the list, dropout rate, and graft survival, in two eras of enlisted patients, before and after the introduction of the macroarea sharing policy in Italy. With the intent to minimize the presence of possible selection biases, the two groups were matched trough Propensity Score Matching (PSM).
A retrospective multi-centre study involving six Italian transplant centres was performed using prospectively collected databases from each participating centre, registering MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.
Study population was divided in two groups according to the time of waiting list before or after the introduction of MELD ≥ 30 allocation scheme: ERA-1 Group (August 2010 - July 2014), and ERA-2 Group (August 2014 - July 2018).
Primary endpoint was waiting list time across different eras in patients above and below MELD ≥ 30 cutoff. Secondary endpoints were dropout rate as well as patient and graft survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERA-1 Group | Before the introduction of the MELD≥30 allocation scheme August 2010 - July 2014 |
| |
| ERA-2 Group | After the introduction of the MELD≥30 allocation scheme August 2014 - July 2018 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver Transplantation | Procedure | Use prospectively collected databases from each participate centre, register MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Survival since waiting list and after liver transplantation | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Survival | Survival of the graft since liver transplantation | 5 year |
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Inclusion Criteria:
- LT patients registered from August 2010 to July 2018
Exclusion Criteria:
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4,238 LT patients registered from August 2010 to July 2018 have been initially enrolled for the analysis (Bologna=961, Pisa=980, Turin=897, Milan Niguarda=859, Rome Sapienza=268, Rome Cattolica=273), and categorized in an ERA-1 Group (n=2,225; before macroarea priority allocation), and an ERA-2 Group (n=2,013; after macroarea priority allocation).
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| Name | Affiliation | Role |
|---|---|---|
| Matteo Ravaioli, Professor | Sant'Orsola-Malpighi Hospital, University of Bologna | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16827857 | Background | Ravaioli M, Grazi GL, Ballardini G, Cavrini G, Ercolani G, Cescon M, Zanello M, Cucchetti A, Tuci F, Del Gaudio M, Varotti G, Vetrone G, Trevisani F, Bolondi L, Pinna AD. Liver transplantation with the Meld system: a prospective study from a single European center. Am J Transplant. 2006 Jul;6(7):1572-7. doi: 10.1111/j.1600-6143.2006.01354.x. | |
| 11172350 |
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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 |
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| OTHER |
| Catholic University of the Sacred Heart | OTHER |
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| 31074921 | Background | Jasseron C, Francoz C, Antoine C, Legeai C, Durand F, Dharancy S; collaborators. Impact of the new MELD-based allocation system on waiting list and post-transplant survival - a cohort analysis using the French national CRISTAL database. Transpl Int. 2019 May 10. doi: 10.1111/tri.13448. Online ahead of print. |
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| 30086090 | Background | Yoo S, Jang EJ, Yi NJ, Kim GH, Kim DH, Lee H, Jung CW, Ryu HG. Effect of Institutional Case Volume on In-hospital Mortality After Living Donor Liver Transplantation: Analysis of 7073 Cases Between 2007 and 2016 in Korea. Transplantation. 2019 May;103(5):952-958. doi: 10.1097/TP.0000000000002394. |
| 34774638 | Derived | Ravaioli M, Lai Q, Sessa M, Ghinolfi D, Fallani G, Patrono D, Di Sandro S, Avolio A, Odaldi F, Bronzoni J, Tandoi F, De Carlis R, Pascale MM, Mennini G, Germinario G, Rossi M, Agnes S, De Carlis L, Cescon M, Romagnoli R, De Simone P. Impact of MELD 30-allocation policy on liver transplant outcomes in Italy. J Hepatol. 2022 Mar;76(3):619-627. doi: 10.1016/j.jhep.2021.10.024. Epub 2021 Nov 10. |
| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |