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

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.

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Publication Details

Journal
Updates in Surgery
Published
2025-03-27
DOI
https://doi.org/10.1007/s13304-025-02078-4
Citations
5
Primary Topic
Organ Transplantation Techniques and Outcomes
Type
article
Field-Weighted Citation Impact
10.03

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article

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

Gabriele Spoletini, Martín de Santibañes, M. Thamara P. R. Perera, Bunthoon Noonthasoot et al.
5 citations
Updates in Surgery
Organ Transplantation Techniques and Outcomes
10.03
article

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

Gabriele Spoletini, Martín de Santibañes, M. Thamara P. R. Perera, Bunthoon Noonthasoot, Felix Braun, Giuliano Testa, Vatche G. Agopian, Gabriel C. Oniscu, Olga Ciccarelli, Takashi Ito, Ilka Boin, Marco Maria Pascale, Giovanni Vennarecci, Kristopher P. Croome, Cristiano Quintini, Burcin Ekser, Renato Romagnoli, Fabrizio Di Benedetto, Daniel G. Maluf, Patrizia Burra, Umberto Cillo, Carlo Pulitanò, Gilberto Mejía, Zhishui Chen, Marco Vivarelli, Brian Nguyen, Matteo Cescon, Sunhawit Junrungsee, Silvio Nadalin, Luciano De Carlis, Mikel Gastaca, Amedeo Carraro, Ephrem Salamé, Salvatore Gruttadauria, Madhukar S. Patel, Timuçin Taner, Deniz Balcı, Ian Leipnitz, Wojciech G. Polak, Vincenzo Mazzaferro, Tina Pasciuto, Nguyen Quang Nghia, Stefania Camagni, Michał Grąt, Mickaël Lesurtel, Feiwen Deng, Marcos V. Perini, Paulo N. Martins, L. Caccamo, A.W. Avolio, John Hammond, Francesco Tandoi, Júlio César Wiederkehr, Riccardo Pravisani, Diana Giannarelli, A. R. Monakhov, Quirino Lai, Marta Garcia‐Guix, Subhash Gupta, Zhiyong Guo, Hiroto Egawa, Giuseppe Maria Ettorre, Jean Yves Mabrut, Gonzalo Sapisochin, Davide Ghinolfi, Giuseppe Tisone, Surendran Sudhindran, Zemin Hu
article en
5 citations

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.

Updates in SurgeryVol. 77(3)
Università Cattolica del Sacro Cuore (IT), University of Pisa (IT), Université de Tours (FR), University of Rome Tor Vergata (IT), University of Modena and Reggio Emilia (IT), University of Maryland, Baltimore (US), Amrita Institute of Medical Sciences and Research Centre (IN), University of Udine (IT), Cliniques Universitaires Saint-Luc (BE), Mayo Clinic (US), Karolinska University Hospital (SE), Ankara University (TR), University of Auckland (NZ), Sun Yat-sen University (CN), Chulalongkorn University (TH), University of California, Los Angeles (US), University of Massachusetts Chan Medical School (US), Universidade Estadual de Campinas (UNICAMP) (BR), Georgetown University (US), Université Paris Cité (FR), Kyoto University (JP), Medical University of Warsaw (PL), Queen Elizabeth Hospital Birmingham (GB), Hôpital Beaujon (FR), Royal Prince Alfred Hospital (AU), Austin Hospital (AU), Jacksonville College (US), Newcastle upon Tyne Hospitals NHS Foundation Trust (GB), Toronto General Hospital (CA), Hospital Italiano de Buenos Aires (AR), Max Super Speciality Hospital (IN), MedStar Georgetown University Hospital (US), Agostino Gemelli University Polyclinic (IT), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), North Chiang Mai University (TH), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Antonio Cardarelli (IT), Hôpital de la Croix-Rousse (FR), Hospital de Basurto (ES), Universitätsklinikum Tübingen (DE), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT), Azienda Ospedaliera San Camillo-Forlanini (IT), IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT), Hospital Santa Paula (BR), Hospices Civils de Lyon (FR), Universidade Regional de Blumenau (BR), First People's Hospital of Foshan (CN), Ospedale Papa Giovanni XXIII (IT), Ospedali Riuniti di Ancona (IT), Zhongshan People's Hospital (CN), V.I.Shumakov Federal Research Center of Transplantology and Artificial Organs (RU), University Hospital Schleswig-Holstein (DE), Mayo Clinic in Arizona (US), The First Affiliated Hospital, Sun Yat-sen University (CN), IRCCS San Camillo Hospital (IT), National Cancer Institute (MY), Tokyo Women's Medical University (JP), Institute of Cardiology (CO), Hospital de Cruces (ES), Central Clinical Hospital (PL), Mayo Clinic in Florida (US), Azienda Ospedale - Università Padova (IT), Erasmus MC Cancer Institute (NL), Carlo Forlanini Hospital (IT), Viet Duc Hospital (VN), Tongji Hospital (CN), Baylor Scott & White All Saints Medical Center (US), Indiana University School of Medicine, Chiang Mai University (TH), Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (IT), Indiana University – Purdue University Indianapolis (US), Universitat de Barcelona (ES), Bharath University (IN), Sapienza University of Rome (IT), The University of Texas Southwestern Medical Center (US), Erasmus University Rotterdam (NL), University of Lübeck (DE)
Baylor University, Università Degli Studi di Modena e Reggio Emila, Università degli Studi di Milano, Università degli Studi di Milano-Bicocca, Ministero della Salute, Tongji University, Università Cattolica del Sacro Cuore, Universidade Estadual de Campinas, Hospices Civils de Lyon, Università di Pisa, Università degli Studi di Roma Tor Vergata, School of Medicine, Indiana University, Baylor University Medical Center, Erasmus Universitair Medisch Centrum Rotterdam, National Cancer Institute, David Geffen School of Medicine, University of California, Los Angeles
Openalex Percentile: Top 2%
Organ Transplantation Techniques and Outcomes
10.03
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