Hypothermic Machine Perfusion in Liver Transplantation — A Randomized Trial: a randomized trial

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Titel: Hypothermic Machine Perfusion in Liver Transplantation — A Randomized Trial: a randomized trial
Autoren: Rijn, R. van, Schurink, I.J., Vries, Y. de, Berg, A.P. van den, Cerisuelo, M.C., Murad, S.D., Erdmann, J.I., Gilbo, N., Haas, R.J. de, Heaton, N., Hoek, B. van, Huurman, V.A.L., Jochmans, I., Leeuwen, O.B. van, Meijer, V.E. de, Monbaliu, D., Polak, W.G., Slangen, J.J.G., Troisi, R.I., Vanlander, A., Jonge, J. de, Porte, R.J., DHOPE DCD Trial Investigators
Weitere Verfasser: Surgery
Quelle: New England Journal of Medicine. 384:1391-1401
Verlagsinformationen: Massachusetts Medical Society, 2021.
Publikationsjahr: 2021
Schlagwörter: Adult, Male, Constriction, Pathologic, Sciences de la santé humaine, perfusion, 03 medical and health sciences, Medicine, General & Internal, 0302 clinical medicine, General & Internal Medicine, Reperfusion Injury/prevention & control, Humans, Human health sciences, Chirurgie, Biliary Tract, 11 Medical and Health Sciences, Constriction, Pathologic/prevention & control, Science & Technology, 42 Health sciences, liver transplantation, Cold Ischemia, Organ Preservation/methods, 32 Biomedical and clinical sciences, Organ Preservation, Middle Aged, Biliary Tract/pathology, Liver Transplantation, 3. Good health, Cold Temperature, Perfusion, DHOPE-DCD Trial Investigators, Reperfusion Injury, Surgery, Female, Life Sciences & Biomedicine
Beschreibung: Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited.In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications.A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P = 0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups.Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283.).
Publikationsart: Article
Dateibeschreibung: application/pdf
Sprache: English
ISSN: 1533-4406
0028-4793
DOI: 10.1056/nejmoa2031532
Zugangs-URL: https://pubmed.ncbi.nlm.nih.gov/33626248
http://hdl.handle.net/11588/880645
https://research.rug.nl/en/publications/7fa64493-0fc6-4b85-a4c2-d51cb7c4fded
https://hdl.handle.net/11370/7fa64493-0fc6-4b85-a4c2-d51cb7c4fded
https://doi.org/10.1056/NEJMoa2031532
https://research.rug.nl/en/publications/hypothermic-machine-perfusion-in-liver-transplantation-a-randomiz
https://www.nejm.org/doi/full/10.1056/NEJMoa2031532
https://europepmc.org/article/MED/33626248
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2031532/suppl_file/nejmoa2031532_data-sharing.pdf
https://www.ncbi.nlm.nih.gov/pubmed/33626248
https://pubmed.ncbi.nlm.nih.gov/33626248/
https://hdl.handle.net/1887/3270941
https://pure.amsterdamumc.nl/en/publications/86a1d5e6-dd77-4a46-bc39-f908477279a4
https://doi.org/10.1056/NEJMoa2031532
https://hdl.handle.net/2268/311978
https://doi.org/10.1056/NEJMoa2031532
https://biblio.vub.ac.be/vubir/hypothermic-machine-perfusion-in-liver-transplantation--a-randomized-trial(c42ce8b8-9f51-46a7-aa36-cfb5e028afb1).html
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CC BY
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Dokumentencode: edsair.doi.dedup.....1a2a0e0e5417bddf675d9df991c51766
Datenbank: OpenAIRE
Beschreibung
Abstract:Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited.In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications.A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P = 0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups.Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283.).
ISSN:15334406
00284793
DOI:10.1056/nejmoa2031532