Evidence map›Paper›PMID 40146444›Full record

Observational studyUpdates in surgery2025

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, Gabriele Spoletini, Umberto Cillo, Kristopher Croome, Gabriel Oniscu, Patrizia Burra, Martin De Santibanes, Hiroto Egawa, Mikel Gastaca, Zhiyong Guo and 60 more

Abstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Updates in surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

70 authors.

Alfonso W Avolio *General Surgery and Transplantation Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. alfonso.avolio@unicatt.it.ORCID http://orcid.org/0000-0003-2491-7625
Gabriele Spoletini *General Surgery and Transplantation Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Umberto Cillo *General Surgey 2 Hepatobiliopancreatic Surgery and Liver Transplan Unit, Azienda Ospedaliera Universitaria, Padua, Italy.
Kristopher Croome *Division of Transplant Surgery, Department of Transplant, Mayo Clinic, Jacksonville, FL, USA.
Gabriel Oniscu *Division of Transplantation, Clintec Karolinska University Hospital, Stockholm, Sweden.
Patrizia Burra *Multivisceral Transplant Unit, Azienda Ospedaliera Universitaria, Padua, Italy.
Martin De Santibanes *Department of Hepato-Biliary, Pancreatic Surgery & Liver Transplant Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Hiroto Egawa *Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Shizuoka, Japan.
Mikel Gastaca *Unidad de Cirugía Hepatobiliar y Trasplante Hepático, Hospital Universitario Cruces-Bilbao, Bilbao, Spain.
Zhiyong Guo *Organ Transplant Center, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Quirino Lai *Hepato-Bilio-Pancreatic and Liver Transplant Unit, Department of Surgery, Sapienza University, Rome, Italy.
Paulo N Martins *Transplant Division, Dept of Surgery, University of Massachusetts, Worcester, MA, USA.
Wojciech G Polak *Department of Surgery, Division of HPB and Transplant Surgery, Erasmus MC Transplant Institute, University MC Rotterdam, Rotterdam, the Netherlands.
Cristiano Quintini *Department of Liver Transplantation, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates.
Mohamed Rela *Institute of Liver Disease and Transplantation, Dr Rela Institute and Medical center, Bharath Institute of Higher Education and Research, Chennai, India.
Gonzalo Sapisochin *Multiorgan Transplantation, Toronto General Hospital, Toronto, Canada.
Julio Wiederkehr *Liver Transplant Division, Hospital Santa Isabel, Blumenau, Brazil.
Riccardo PravisaniLiver-Kidney Transplant Unit, Università di Udine - ASUFC, Udine, Italy.
Deniz BalciLiver Transplantation Unit, Department of General Surgery, Faculty of Medicine, Ankara University, Ankara, Turkey.
Ian LeipnitzLiver Transplant Unit, University of Auckland, Auckland, New Zealand.
Ilka BoinLiver Transplantation Unit, University of Campinas-UNICAMP, S. Paolo, Brazil.
Felix BraunDepartment of General, Visceral-, Thoracic-, Transplant- and Pediatric-Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Lucio CaccamoGeneral and Liver Transplant Surgery, Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico Milano, Milan, Italy.
Stefania CamagniDepartment of Organ Failure and Transplantation, ASST Papa Giovanni XXIII, Bergamo, Italy.
Amedeo CarraroLiver Transplant Unit, University Hospital Trust of Verona, Verona, Italy.
Matteo CesconGeneral Surgery and Transplant Unit, Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna, Italy.
Zhishui ChenLaboratory of Organ Transplantation, Institute of Organ Transplantation, Tongji Hospital, Wuhan, China.
Olga CiccarelliService de Chirurgie et Transplantation Abdominal, Cliniques Universtaires Saint-Luc, Louvein, Belgium.
Luciano De CarlisGeneral Surgery and Abdominal Transplantation Unit, University of Milano-Bicocca and Niguarda-CàGranda Hospital, Milan, Italy.
Deng FeiwenDepartment of Hepatopancreas Surgery, Foshan First People's Hospital, Foshan, China.
Fabrizio Di BenedettoHepato-Pancreato-Biliary Surgery and Liver Transplantation Unit, University of Modena and Reggio Emilia, Modena, Italy.
Burcin EkserDivision of Transplant Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
Giuseppe Maria EttorreDepartment of General Surgery and Transplantation Unit, A.O. San Camillo-Forlanini, Rome, Italy.
Marta Garcia-GuixDivision of Hepatobiliary and Liver Transplantation, Department of Surgery, University of Barcelona, Barcelona, Spain.
Davide GhinolfiDivision of Hepatic Surgery and Liver Transplantation, University of Pisa Hospital, Pisa, Italy.
Michal GratTransplant and Liver Surgery, Public Central Teaching Hospital, Medical University of Warsaw, Warsaw, Poland.
Salvatore GruttadauriaAbdominal Transplantation, IRCCS ISMETT - UPMC, Palermo, Italy.
John HammondHPB and Transplant Surgery, Newcastle Hospital NHS Foundation Trust, Newcastle, UK.
Zemin HuGeneral Surgery 1, Zhongshan People's Hospital, Zhongshan, China.
Sunhawit JunrungseeDivision of Hepato-Biliary-Pancreas Surgery, Chiang Mai University, Chiang Mai, Thailand.
Michael LesurtelDepartment of HPB Surgery & Liver Transplantation, Beaujon Hospital, Université Paris Cité, Paris, France.
Jean Yves MabrutDepartment of General Surgery and Liver Transplantation, Croix-Rousse University Hospital, Hospices Civils de Lyon, Lyon, France.
Daniel MalufDepartment of Surgery, University of Maryland, Baltimore, MD, USA.
Vincenzo MazzaferroGeneral Surgery and Liver Transplantation Unit, University of Milan and National Cancer Institute, IRCCS, Milan, Italy.
Gilberto MejiaTransplant Surgery, Fundacion CardioInfantil, Bogotà, Colombia.
Artem MonakhovSurgical Department #2 (Liver Transplantation), National Medical Research Center of Transplantation and Artificial Organs named after V.I. Shumakov, Moscow, Russia.
Bunthoon NoonthasootDepartment of Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Silvio NadalinDepartment of General, Visceral and Transplant Surgery, Universitätsklinik Tübingen, Tubingen, Germany.
Brian M NguyenMedStar Georgetown Transplant Institute, MedStar Georgetown University Hospital, Georgetown, Washington, DC, USA.
Nguyen Quang NghiaCenter of Organ Transplantation, Viet Duc University Hospital, Hanoi, Vietnam.
Madhukar PatelLiver Transplantation Unit, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Thamara PereraTransplant Surgery, Queen Elizabeth Hospital, Birmingham, UK.
Marcos Vinicius PeriniLiver Transplantation Unit, Austin Hospital, Melbourne, VIC, Australia.
Carlo PulitanoAustralian National Liver Transplantation Unit, Royal Prince Alfred Hospital, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Renato RomagnoliGeneral Surgery 2U, Liver Transplantation Center, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
Ephrem SalameDepartment of Digestive, Hepatobiliary and Pancreatic Surgery, Regional University Hospital, Tours, France.
Gupta Subhashcenter for Liver and Biliary Science, Max Super Speciality Hospital Saket, New Delhi, India.
Surendran SudhindranDept of GI Surgery, Amrita Institute of Medical Sciences (Amrita Hospital), Kochi, India.
Takashi ItoDept of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Francesco TandoiHepatobiliary Surgery and Liver Transplantation, AOU Policlinico Consorziale di Bari, Bari, Italy.
Giuliano TestaBaylor Scott & White, All Saints Medical Center & Baylor University Medical Center, Ft. Worth & Dallas, TX, USA.
Timucin TanerCenter for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, MN, USA.
Giuseppe TisoneHPB and Transplant Unit, Department of Surgical Sciences, University of Rome Tor Vergata, Rome, Italy.
Giovanni VennarecciUOC Hepato-Biliary Surgery and Liver Transplant center, A.O.R.N.A. CARDARELLI, Naples, Italy.
Marco VivarelliHepatobiliary and Abdominal Transplantation Surgery, Ancona Hospital, Ancona, Italy.
Diana GiannarelliDept Epidemiology and Biostatistics, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy.
Tina PasciutoHygiene Unit, University Department of Life Sciences and Public Health, Università Cattolica Del Sacro Cuore, Rome, Italy.
Marco Maria PascaleGeneral Surgery and Transplantation Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Vatche Agopian *Division of Liver and Pancreas Transplantation, Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
and the global IMPROVEMENT study group

Funding

Ministero della Salute RF-2021-12372422
6 · The paper itself

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.

Indexed as

Graft RejectionLiver TransplantationAllograftsHumansMulticenter Studies as TopicObservational Studies as TopicProspective StudiesRisk AssessmentTime FactorsAllograft failureIschemic cholangiopathyLiver transplantOutcomePrimary dysfunctionRetransplant

Identifiers

PMID40146444
PMCPMC12226705

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.