Article (Scientific journals)
Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines.
Martins, Paulo N; Rizzari, Michael D; Ghinolfi, Davide et al.
2021In Transplantation, 105 (4), p. 796-815
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Keywords :
Consensus; Endpoint Determination; Humans; Liver Transplantation/adverse effects; Organ Preservation/adverse effects; Perfusion/adverse effects; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
Abstract :
[en] BACKGROUND: Recent trials in liver machine perfusion (MP) have revealed unique challenges beyond those seen in most clinical studies. Correct trial design and interpretation of data are essential to avoid drawing conclusions that may compromise patient safety and increase costs. METHODS: The International Liver Transplantation Society, through the Special Interest Group "DCD, Preservation and Machine Perfusion," established a working group to write consensus statements and guidelines on how future clinical trials in liver perfusion should be designed, with particular focus on relevant clinical endpoints and how different techniques of liver perfusion should be compared. Protocols, abstracts, and full published papers of clinical trials using liver MP were reviewed. The use of a simplified Grading of Recommendations Assessment, Development, and Evaluation working group (GRADE) system was attempted to assess the level of evidence. The working group presented its conclusions at the International Liver Transplantation Society consensus conference "DCD, Liver Preservation, and Machine Perfusion" held in Venice, Italy, on January 31, 2020. RESULTS: Twelve recommendations were proposed with the main conclusions that clinical trials investigating the effect of MP in liver transplantation should (1) make the protocol publicly available before the start of the trial, (2) be adequately powered, and (3) carefully consider timing of randomization in function of the primary outcome. CONCLUSIONS: There are issues with using accepted primary outcomes of liver transplantation trials in the context of MP trials, and no ideal endpoint could be defined by the working group. The setup of an international registry was considered vital by the working group.
Disciplines :
Surgery
Gastroenterology & hepatology
Author, co-author :
Martins, Paulo N;  Division of Organ Transplantation, Department of Surgery, University of
Rizzari, Michael D;  Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit,
Ghinolfi, Davide;  Division of Hepatobiliary Surgery and Liver Transplantation, University of Pisa
Jochmans, Ina;  Transplantation Research Group, Lab of Abdominal Transplantation, Department of  ; Department of Abdominal Transplant Surgery, University Hospitals Leuven, Leuven,
Attia, Magdy;  Department of Hepatobiliary & Transplantation Surgery, Leeds Teaching Hospitals
Jalan, Rajiv;  Liver Failure Group, UCL Institute for Liver and Digestive Health, UCL Medical
Friend, Peter J;  Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United
ILTS Special Interest Group “DCD, Preservation and Machine Perfusion”
Other collaborator :
Martins, Paulo N
Rizzari, Michael
Attia, Magdy
Ghinolfi, David
Jochmans, Ina
Jalan, Rajiv
Friend, Peter
Broering, Dieter
Grat, Michael
Gugenheim, Jean
Guo, Zhiyong
Jacques, Andrew
Marek, Kysela
Mas, Valeria
Patrono, Damiano
Dondossola, Daniele
Pomfret, Elizabeth
Ruiz, Patricia
Spiritelli, Sandra
Patkowski, Waldemar
DeMuylder, Peter
Ploeg, Rutger
Mergental, Hynek
Abt, Peter L
Attia, Magdy
Clavien, Pierre-A
Cerisuelo, Miriam Cortes
Croome, Kristopher P
Detry, Olivier  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de chirurgie abdo, sénologique, endocrine et de transplantation
Pozzo, Federica Dondero
Dutkowski, Philipp
Foley, David
Fondevilla, Constantino
García-Valdecasas Salgado, Juan Carlos
Gastaca, Mikel
Ghinolfi, Davide
Guarrera, James
Guo, Zhiyong
Heaton, Nigel
Hernandez-Alejandro, Roberto
Hessheimer, Amelia
Jalan, Rajiv
Jochmans, Ina
Kalisvaart, Marit
Maluf, Daniel
Martins, Paulo
Miñambres, Eduardo
Muiesan, Paolo
Nasralla, David
Oniscu, Gabriel
Pirenne, Jacques
Polak, Wojciech
Porte, Robert J
Quintini, Cristiano
Rizzari, Michael
Savier, Eric
Schlegel, Andrea
Taner, C Burcin
Watson, Christopher J E
More authors (49 more) Less
Language :
English
Title :
Design, Analysis, and Pitfalls of Clinical Trials Using Ex Situ Liver Machine Perfusion: The International Liver Transplantation Society Consensus Guidelines.
Publication date :
01 April 2021
Journal title :
Transplantation
ISSN :
0041-1337
eISSN :
1534-6080
Publisher :
Lippincott Williams & Wilkins, Maryland, Us md
Volume :
105
Issue :
4
Pages :
796-815
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Available on ORBi :
since 29 July 2023

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