NCT04530240

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

8.1 years

First QC Date

August 24, 2020

Last Update Submit

August 24, 2020

Conditions

Liver Transplant DisorderHCC

Keywords

Allocation SystemLiver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Patient Survival

    Survival since waiting list and after liver transplantation

    5 year

Secondary Outcomes (1)

  • Graft Survival

    5 year

Study Arms (2)

ERA-1 Group

Before the introduction of the MELD≥30 allocation scheme August 2010 - July 2014

Procedure: Liver Transplantation

ERA-2 Group

After the introduction of the MELD≥30 allocation scheme August 2014 - July 2018

Procedure: Liver Transplantation

Interventions

Liver TransplantationPROCEDURE

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.

ERA-1 GroupERA-2 Group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • \- LT patients registered from August 2010 to July 2018

You may not qualify if:

  • LT patients registered before August 2010 and after July 2018
  • Data not available for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

  • 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.

    PMID: 16827857BACKGROUND

  • Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172.

    PMID: 11172350BACKGROUND

  • Nekrasov V, Matsuoka L, Rauf M, Kaur N, Cao S, Groshen S, Alexopoulos SP. National Outcomes of Liver Transplantation for Model for End-Stage Liver Disease Score >/=40: The Impact of Share 35. Am J Transplant. 2016 Oct;16(10):2912-2924. doi: 10.1111/ajt.13823. Epub 2016 May 13.

    PMID: 27063579BACKGROUND

  • Goldberg DS, Levine M, Karp S, Gilroy R, Abt PL. Share 35 changes in center-level liver acceptance practices. Liver Transpl. 2017 May;23(5):604-613. doi: 10.1002/lt.24749.

    PMID: 28240804BACKGROUND

  • Weismuller TJ, Fikatas P, Schmidt J, Barreiros AP, Otto G, Beckebaum S, Paul A, Scherer MN, Schmidt HH, Schlitt HJ, Neuhaus P, Klempnauer J, Pratschke J, Manns MP, Strassburg CP. Multicentric evaluation of model for end-stage liver disease-based allocation and survival after liver transplantation in Germany--limitations of the 'sickest first'-concept. Transpl Int. 2011 Jan;24(1):91-9. doi: 10.1111/j.1432-2277.2010.01161.x. Epub 2010 Sep 3.

    PMID: 20819196BACKGROUND

  • Habib S, Berk B, Chang CC, Demetris AJ, Fontes P, Dvorchik I, Eghtesad B, Marcos A, Shakil AO. MELD and prediction of post-liver transplantation survival. Liver Transpl. 2006 Mar;12(3):440-7. doi: 10.1002/lt.20721.

    PMID: 16498643BACKGROUND

  • Nicolas CT, Nyberg SL, Heimbach JK, Watt K, Chen HS, Hathcock MA, Kremers WK. Liver transplantation after share 35: Impact on pretransplant and posttransplant costs and mortality. Liver Transpl. 2017 Jan;23(1):11-18. doi: 10.1002/lt.24641. Epub 2016 Dec 5.

    PMID: 27658200BACKGROUND

  • Ravaioli M, Grande G, Di Gioia P, Cucchetti A, Cescon M, Ercolani G, Del Gaudio M, Morelli C, Pinna AD. Risk Avoidance and Liver Transplantation: A Single-center Experience in a National Network. Ann Surg. 2016 Nov;264(5):778-786. doi: 10.1097/SLA.0000000000001887.

    PMID: 27429038BACKGROUND

  • Nagai S, Chau LC, Schilke RE, Safwan M, Rizzari M, Collins K, Yoshida A, Abouljoud MS, Moonka D. Effects of Allocating Livers for Transplantation Based on Model for End-Stage Liver Disease-Sodium Scores on Patient Outcomes. Gastroenterology. 2018 Nov;155(5):1451-1462.e3. doi: 10.1053/j.gastro.2018.07.025. Epub 2018 Jul 26.

    PMID: 30056096BACKGROUND

  • Kwong AJ, Goel A, Mannalithara A, Kim WR. Improved posttransplant mortality after share 35 for liver transplantation. Hepatology. 2018 Jan;67(1):273-281. doi: 10.1002/hep.29301. Epub 2017 Nov 13.

    PMID: 28586179BACKGROUND

  • Beal EW, Black SM, Mumtaz K, Hayes D Jr, El-Hinnawi A, Washburn K, Tumin D. High Center Volume Does Not Mitigate Risk Associated with Using High Donor Risk Organs in Liver Transplantation. Dig Dis Sci. 2017 Sep;62(9):2578-2585. doi: 10.1007/s10620-017-4639-2. Epub 2017 Jun 1.

    PMID: 28573507BACKGROUND

  • Kang S, Little RJ, Kaciroti N. Missing not at random models for masked clinical trials with dropouts. Clin Trials. 2015 Apr;12(2):139-48. doi: 10.1177/1740774514566662. Epub 2015 Jan 27.

    PMID: 25627429BACKGROUND

  • Caliendo M, Kopeinig S. Some practical guidance for the implementation of propensity score matching. J Econ Surv. 2008; 22:31-72

    BACKGROUND

  • Austin PC, Lee DS, Fine JP. Introduction to the Analysis of Survival Data in the Presence of Competing Risks. Circulation. 2016 Feb 9;133(6):601-9. doi: 10.1161/CIRCULATIONAHA.115.017719.

    PMID: 26858290BACKGROUND

  • Nekrasov V, Matsuoka L, Kaur N, Pita A, Whang G, Cao S, Groshen S, Alexopoulos S. Improvement in the Outcomes of MELD >/= 40 Liver Transplantation: An Analysis of 207 Consecutive Transplants in a Highly Competitive DSA. Transplantation. 2017 Oct;101(10):2360-2367. doi: 10.1097/TP.0000000000001738.

    PMID: 28319564BACKGROUND

  • Luo X, Leanza J, Massie AB, Garonzik-Wang JM, Haugen CE, Gentry SE, Ottmann SE, Segev DL. MELD as a metric for survival benefit of liver transplantation. Am J Transplant. 2018 May;18(5):1231-1237. doi: 10.1111/ajt.14660. Epub 2018 Feb 19.

    PMID: 29316310BACKGROUND

  • Ravaioli M, Grazi GL, Ercolani G, Cescon M, Del Gaudio M, Zanello M, Ballardini G, Varotti G, Vetrone G, Tuci F, Lauro A, Ramacciato G, Pinna AD. Liver allocation for hepatocellular carcinoma: a European Center policy in the pre-MELD era. Transplantation. 2006 Feb 27;81(4):525-30. doi: 10.1097/01.tp.0000198741.39637.44.

    PMID: 16495798BACKGROUND

  • Ghinolfi D, Lai Q, Pezzati D, De Simone P, Rreka E, Filipponi F. Use of Elderly Donors in Liver Transplantation: A Paired-match Analysis at a Single Center. Ann Surg. 2018 Aug;268(2):325-331. doi: 10.1097/SLA.0000000000002305.

    PMID: 28549011BACKGROUND

  • Cillo U, Burra P, Mazzaferro V, Belli L, Pinna AD, Spada M, Nanni Costa A, Toniutto P; I-BELT (Italian Board of Experts in the Field of Liver Transplantation). A Multistep, Consensus-Based Approach to Organ Allocation in Liver Transplantation: Toward a "Blended Principle Model". Am J Transplant. 2015 Oct;15(10):2552-61. doi: 10.1111/ajt.13408. Epub 2015 Aug 14.

    PMID: 26274338BACKGROUND

  • Sundaram V, Kogachi S, Wong RJ, Karvellas CJ, Fortune BE, Mahmud N, Levitsky J, Rahimi RS, Jalan R. Effect of the clinical course of acute-on-chronic liver failure prior to liver transplantation on post-transplant survival. J Hepatol. 2020 Mar;72(3):481-488. doi: 10.1016/j.jhep.2019.10.013. Epub 2019 Oct 25.

    PMID: 31669304BACKGROUND

  • 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.

    PMID: 31074921BACKGROUND

  • Tschuor C, Ferrarese A, Kuemmerli C, Dutkowski P, Burra P, Clavien PA; Liver Allocation Study Group. Allocation of liver grafts worldwide - Is there a best system? J Hepatol. 2019 Oct;71(4):707-718. doi: 10.1016/j.jhep.2019.05.025. Epub 2019 Jun 12.

    PMID: 31199941BACKGROUND

  • Ishaque T, Massie AB, Bowring MG, Haugen CE, Ruck JM, Halpern SE, Waldram MM, Henderson ML, Garonzik Wang JM, Cameron AM, Philosophe B, Ottmann S, Rositch AF, Segev DL. Liver transplantation and waitlist mortality for HCC and non-HCC candidates following the 2015 HCC exception policy change. Am J Transplant. 2019 Feb;19(2):564-572. doi: 10.1111/ajt.15144. Epub 2018 Nov 9.

    PMID: 30312530BACKGROUND

  • 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.

    PMID: 30086090BACKGROUND

  • 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.

    PMID: 34774638DERIVED

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Matteo Ravaioli, Professor

    Sant'Orsola-Malpighi Hospital, University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 28, 2020

Study Start

August 1, 2010

Primary Completion

August 31, 2018

Study Completion

December 31, 2019

Last Updated

August 28, 2020

Record last verified: 2020-08