Paulo N Martins1, Michael D Rizzari2, Davide Ghinolfi3, Ina Jochmans4,5, Magdy Attia6, Rajiv Jalan7, Peter J Friend8. 1. Division of Organ Transplantation, Department of Surgery, University of Massachusetts Memorial Hospital, University of Massachusetts, Worcester, MA. 2. Division of Transplant and Hepatobiliary Surgery, Henry Ford Hospital, Detroit, MI. 3. Division of Hepatobiliary Surgery and Liver Transplantation, University of Pisa Medical School Hospital, Pisa, Tuscany, Italy. 4. Transplantation Research Group, Lab of Abdominal Transplantation, Department of Microbiology, Immunology and Transplantation, KU Leuven, Belgium. 5. Department of Abdominal Transplant Surgery, University Hospitals Leuven, Leuven, Belgium. 6. Department of Hepatobiliary & Transplantation Surgery, Leeds Teaching Hospitals Trust, Leeds, United Kingdom. 7. Liver Failure Group, UCL Institute for Liver and Digestive Health, UCL Medical School, London, United Kingdom. 8. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
Abstract
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.
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.
Authors: Margot Fodor; Lukas Lanser; Julia Hofmann; Giorgi Otarashvili; Marlene Pühringer; Benno Cardini; Rupert Oberhuber; Thomas Resch; Annemarie Weissenbacher; Manuel Maglione; Christian Margreiter; Philipp Zelger; Johannes D Pallua; Dietmar Öfner; Robert Sucher; Theresa Hautz; Stefan Schneeberger Journal: Transpl Int Date: 2022-05-16 Impact factor: 3.842
Authors: Isabel M A Brüggenwirth; Matteo Mueller; Veerle A Lantinga; Stefania Camagni; Riccardo De Carlis; Luciano De Carlis; Michele Colledan; Daniele Dondossola; Moritz Drefs; Janina Eden; Davide Ghinolfi; Dionysios Koliogiannis; Georg Lurje; Tommaso M Manzia; Diethard Monbaliu; Paolo Muiesan; Damiano Patrono; Johann Pratschke; Renato Romagnoli; Michel Rayar; Federico Roma; Andrea Schlegel; Philipp Dutkowski; Robert J Porte; Vincent E de Meijer Journal: Am J Transplant Date: 2022-04-05 Impact factor: 9.369