Avolio Alfonso W, Spoletini Gabriele, Cillo Umberto, Croome Kristopher, Oniscu Gabriel, Burra Patrizia, De Santibanes Martin, Egawa Hiroto, Gastaca Mikel, Guo Zhiyong, Lai Quirino, Martins Paulo N, Polak Wojciech G, Quintini Cristiano, Rela Mohamed, Sapisochin Gonzalo, Wiederkehr Julio, Pravisani Riccardo, Balci Deniz, Leipnitz Ian, Boin Ilka, Braun Felix, Caccamo Lucio, Camagni Stefania, Carraro Amedeo, Cescon Matteo, Chen Zhishui, Ciccarelli Olga, De Carlis Luciano, Feiwen Deng, Di Benedetto Fabrizio, Ekser Burcin, Ettorre Giuseppe Maria, Garcia-Guix Marta, Ghinolfi Davide, Grat Michal, Gruttadauria Salvatore, Hammond John, Hu Zemin, Junrungsee Sunhawit, Lesurtel Michael, Mabrut Jean Yves, Maluf Daniel, Mazzaferro Vincenzo, Mejia Gilberto, Monakhov Artem, Noonthasoot Bunthoon, Nadalin Silvio, Nguyen Brian M, Nghia Nguyen Quang, Patel Madhukar, Perera Thamara, Perini Marcos Vinicius, Pulitano Carlo, Romagnoli Renato, Salame Ephrem, Subhash Gupta, Sudhindran Surendran, Ito Takashi, Tandoi Francesco, Testa Giuliano, Taner Timucin, Tisone Giuseppe, Vennarecci Giovanni, Vivarelli Marco, Giannarelli Diana, Pasciuto Tina, Pascale Marco Maria, Agopian Vatche
General Surgery and Transplantation Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
General Surgey 2 Hepatobiliopancreatic Surgery and Liver Transplan Unit, Azienda Ospedaliera Universitaria, Padua, Italy.
Updates Surg. 2025 Mar 27. doi: 10.1007/s13304-025-02078-4.
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.
由于扩大标准供体（ECD）的存在，全球范围内进行了更多的肝移植（LT）手术。与此同时，在术后90天和365天时，同种异体移植物失败（AF）的风险被认为有所增加。本研究旨在描绘全球范围内的肝移植实践情况，研究移植物失败的预测模型以及风险缓解策略对进一步改善移植物和患者预后的影响。这是一项多中心、国际性、非竞争性的观察性两段式研究，研究对象为两个时间段（2017 - 2019年和2022 - 2024年）内连续进行的肝移植手术。一个由肝移植专家组成的指导委员会制定了研究方案。前瞻性部分将从15个高容量肝移植中心招募750名患者（每个中心50名），回顾性部分将从56个肝移植中心招募4200名患者（每个中心75名）。目的是提供全球肝移植活动的概况，并开发新的算法，以便及时预测肝移植术后90天和365天时的移植物失败情况。该研究还旨在：（1）验证现有的预测模型；（2）研究再次移植的最佳时机，同时关注不同供体类型以及在各种情况下实施的缓解策略所导致的移植物失败和缺血性胆管病的差异。由于全球范围内机器灌注的采用率已按不同比例增加，模型将根据此参数进行调整。最后，回顾性和前瞻性数据将可用于根据移植时的失代偿程度、性别匹配、术后并发症及其处理进行进一步分层和建模。本方案已获得圣心天主教大学综合医院阿戈斯蒂诺·杰梅利IRCCS伦理委员会（研究编号：4571）以及加利福尼亚大学洛杉矶分校机构审查委员会的批准。临时研究方案已提交给移植领域的主要国际科学协会。研究结果将发表在国际同行评审期刊上，并在大会上展示。
