TY - JOUR
T1 - Protocol for an international multicenter, prospective, observational, non-competitive, study to validate and optimise prediction models of 90-day and 1-year allograft failure after liver transplantation
T2 - The global IMPROVEMENT Study
AU - Avolio, Alfonso W.
AU - Spoletini, Gabriele
AU - Cillo, Umberto
AU - the global IMPROVEMENT study Group
AU - Croome, Kristopher
AU - Oniscu, Gabriel
AU - Burra, Patrizia
AU - De Santibanes, Martin
AU - Egawa, Hiroto
AU - Gastaca, Mikel
AU - Guo, Zhiyong
AU - Lai, Quirino
AU - Martins, Paulo N.
AU - Polak, Wojciech G.
AU - Quintini, Cristiano
AU - Rela, Mohamed
AU - Sapisochin, Gonzalo
AU - Wiederkehr, Julio
AU - Pravisani, Riccardo
AU - Balci, Deniz
AU - Leipnitz, Ian
AU - Boin, Ilka
AU - Braun, Felix
AU - Caccamo, Lucio
AU - Camagni, Stefania
AU - Carraro, Amedeo
AU - Cescon, Matteo
AU - Chen, Zhishui
AU - Ciccarelli, Olga
AU - De Carlis, Luciano
AU - Feiwen, Deng
AU - Di Benedetto, Fabrizio
AU - Ekser, Burcin
AU - Ettorre, Giuseppe Maria
AU - Garcia-Guix, Marta
AU - Ghinolfi, Davide
AU - Grat, Michal
AU - Gruttadauria, Salvatore
AU - Hammond, John
AU - Hu, Zemin
AU - Junrungsee, Sunhawit
AU - Lesurtel, Michael
AU - Mabrut, Jean Yves
AU - Maluf, Daniel
AU - Mazzaferro, Vincenzo
AU - Mejia, Gilberto
AU - Monakhov, Artem
AU - Noonthasoot, Bunthoon
AU - Nadalin, Silvio
AU - Nguyen, Brian M.
AU - Pascale, Marco Maria
AU - de Goeij, Femke
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/6
Y1 - 2025/6
N2 - More liver transplants (LT) are performed worldwide thanks to extended criteria donors (ECD). This is paralleled by a supposed increased risk of allograft failure (AF) at 90 and 365 days. This study has been designed to portray the LT practice worldwide and investigate models of AF prediction and the impact of risk mitigation strategies for further improving graft and patient outcomes. This is a multicenter, international, non-competitive, observational two segment study on consecutive LTs over two periods (2017-2019 and 2022-2024). A steering committee of LT experts defined the study protocol. The prospective segment will enroll 750 patients from 15 high-volume LT centers (50 per center), and the retrospective segment will enrol 4200 patients from 56 LT centers (75 per center). To provide a snapshot of the LT activity globally and to develop new algorithms for the timely prediction of AF at 90 and 365 days post-LT. The study also aims (1) to validate the existing predictive models and (2) to investigate the best time for re-transplantation, paying attention to the differences in AF and Ischemic cholangiopathy according to the donor types and mitigation strategies implemented in the various settings. Since the adoption of machine perfusion has increased in different proportions worldwide, models will be adjusted according to this parameter. Finally, retrospective and prospective data will be available for further stratifications and modelling according to the degree of decompensation at transplant, gender match, postoperative complications and their management. This protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (study ID: 4571) and the Institutional Review Board of the University of California, Los Angeles. The provisional study protocol was submitted to the main scientific international societies in the transplant field. Results will be published in international peer-reviewed journals and presented at congresses.
AB - More liver transplants (LT) are performed worldwide thanks to extended criteria donors (ECD). This is paralleled by a supposed increased risk of allograft failure (AF) at 90 and 365 days. This study has been designed to portray the LT practice worldwide and investigate models of AF prediction and the impact of risk mitigation strategies for further improving graft and patient outcomes. This is a multicenter, international, non-competitive, observational two segment study on consecutive LTs over two periods (2017-2019 and 2022-2024). A steering committee of LT experts defined the study protocol. The prospective segment will enroll 750 patients from 15 high-volume LT centers (50 per center), and the retrospective segment will enrol 4200 patients from 56 LT centers (75 per center). To provide a snapshot of the LT activity globally and to develop new algorithms for the timely prediction of AF at 90 and 365 days post-LT. The study also aims (1) to validate the existing predictive models and (2) to investigate the best time for re-transplantation, paying attention to the differences in AF and Ischemic cholangiopathy according to the donor types and mitigation strategies implemented in the various settings. Since the adoption of machine perfusion has increased in different proportions worldwide, models will be adjusted according to this parameter. Finally, retrospective and prospective data will be available for further stratifications and modelling according to the degree of decompensation at transplant, gender match, postoperative complications and their management. This protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (study ID: 4571) and the Institutional Review Board of the University of California, Los Angeles. The provisional study protocol was submitted to the main scientific international societies in the transplant field. Results will be published in international peer-reviewed journals and presented at congresses.
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=eur_pure&SrcAuth=WosAPI&KeyUT=WOS:001454906400001&DestLinkType=FullRecord&DestApp=WOS_CPL
U2 - 10.1007/s13304-025-02078-4
DO - 10.1007/s13304-025-02078-4
M3 - Article
C2 - 40146444
SN - 2038-131X
VL - 77
SP - 645
EP - 664
JO - Updates in Surgery
JF - Updates in Surgery
IS - 3
M1 - e204095
ER -