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Observational Study
. 2025 Jun;77(3):645-664.
doi: 10.1007/s13304-025-02078-4. Epub 2025 Mar 27.

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: The global IMPROVEMENT Study

Alfonso W Avolio #  1 , Gabriele Spoletini #  2 , Umberto Cillo #  3 , Kristopher Croome #  4 , Gabriel Oniscu #  5 , Patrizia Burra #  6 , Martin De Santibanes #  7 , Hiroto Egawa #  8 , Mikel Gastaca #  9 , Zhiyong Guo #  10 , Quirino Lai #  11 , Paulo N Martins #  12 , Wojciech G Polak #  13 , Cristiano Quintini #  14 , Mohamed Rela #  15 , Gonzalo Sapisochin #  16 , Julio Wiederkehr #  17 , Riccardo Pravisani  18 , Deniz Balci  19 , Ian Leipnitz  20 , Ilka Boin  21 , Felix Braun  22 , Lucio Caccamo  23 , Stefania Camagni  24 , Amedeo Carraro  25 , Matteo Cescon  26 , Zhishui Chen  27 , Olga Ciccarelli  28 , Luciano De Carlis  29 , Deng Feiwen  30 , Fabrizio Di Benedetto  31 , Burcin Ekser  32 , Giuseppe Maria Ettorre  33 , Marta Garcia-Guix  34 , Davide Ghinolfi  35 , Michal Grat  36 , Salvatore Gruttadauria  37 , John Hammond  38 , Zemin Hu  39 , Sunhawit Junrungsee  40 , Michael Lesurtel  41 , Jean Yves Mabrut  42 , Daniel Maluf  43 , Vincenzo Mazzaferro  44 , Gilberto Mejia  45 , Artem Monakhov  46 , Bunthoon Noonthasoot  47 , Silvio Nadalin  48 , Brian M Nguyen  49 , Nguyen Quang Nghia  50 , Madhukar Patel  51 , Thamara Perera  52 , Marcos Vinicius Perini  53 , Carlo Pulitano  54 , Renato Romagnoli  55 , Ephrem Salame  56 , Gupta Subhash  57 , Surendran Sudhindran  58 , Takashi Ito  59 , Francesco Tandoi  60 , Giuliano Testa  61 , Timucin Taner  62 , Giuseppe Tisone  63 , Giovanni Vennarecci  64 , Marco Vivarelli  65 , Diana Giannarelli  66 , Tina Pasciuto  67   68 , Marco Maria Pascale  2 , Vatche Agopian #  69 ; and the global IMPROVEMENT study group
Affiliations
Observational Study

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: The global IMPROVEMENT Study

Alfonso W Avolio et al. Updates Surg. 2025 Jun.

Abstract

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.

Keywords: Allograft failure; Ischemic cholangiopathy; Liver transplant; Outcome; Primary dysfunction; Retransplant.

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Conflict of interest statement

Declarations. Conflict of interest: The authors declare that they do not have competing interests directly or indirectly related to the work. Ethical approval: Fondazione Policlinico Universitario Agostino Gemelli (approval ID 4571). Registration: The study was registered on clinicaltrials.gov (NCT05289609).

Figures

Fig. 1
Fig. 1
International Steering Committee
Fig. 2
Fig. 2
GANTT diagram
Fig. 3
Fig. 3
Rank of countries according to liver transplant activity and rank of enrolled transplants
See this image and copyright information in PMC

References

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