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Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)

BACKGROUND: Pancreas graft quality directly affects morbidity and mortality rates after pancreas transplantation (PTx). The criteria for pancreas graft allocation are restricted, which has decreased the number of available organs. Suitable pancreatic allografts are selected based on donor demographi...

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Autores principales: Kulu, Yakup, Khajeh, Elias, Ghamarnejad, Omid, Nikdad, Mohammadsadegh, Sabagh, Mohammadsadegh, Ali-Hasan-Al-Saegh, Sadeq, Nadalin, Silvio, Quante, Markus, Pisarski, Przemyslaw, Jänigen, Bernd, Reißfelder, Christoph, Mieth, Markus, Morath, Christian, Goeppert, Benjamin, Schirmacher, Peter, Strobel, Oliver, Hackert, Thilo, Zeier, Martin, Springel, Rainer, Schleicher, Christina, Büchler, Markus W., Mehrabi, Arianeb
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478640/
https://www.ncbi.nlm.nih.gov/pubmed/32150070
http://dx.doi.org/10.1097/MD.0000000000019335
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author Kulu, Yakup
Khajeh, Elias
Ghamarnejad, Omid
Nikdad, Mohammadsadegh
Sabagh, Mohammadsadegh
Ali-Hasan-Al-Saegh, Sadeq
Nadalin, Silvio
Quante, Markus
Pisarski, Przemyslaw
Jänigen, Bernd
Reißfelder, Christoph
Mieth, Markus
Morath, Christian
Goeppert, Benjamin
Schirmacher, Peter
Strobel, Oliver
Hackert, Thilo
Zeier, Martin
Springel, Rainer
Schleicher, Christina
Büchler, Markus W.
Mehrabi, Arianeb
author_facet Kulu, Yakup
Khajeh, Elias
Ghamarnejad, Omid
Nikdad, Mohammadsadegh
Sabagh, Mohammadsadegh
Ali-Hasan-Al-Saegh, Sadeq
Nadalin, Silvio
Quante, Markus
Pisarski, Przemyslaw
Jänigen, Bernd
Reißfelder, Christoph
Mieth, Markus
Morath, Christian
Goeppert, Benjamin
Schirmacher, Peter
Strobel, Oliver
Hackert, Thilo
Zeier, Martin
Springel, Rainer
Schleicher, Christina
Büchler, Markus W.
Mehrabi, Arianeb
author_sort Kulu, Yakup
collection PubMed
description BACKGROUND: Pancreas graft quality directly affects morbidity and mortality rates after pancreas transplantation (PTx). The criteria for pancreas graft allocation are restricted, which has decreased the number of available organs. Suitable pancreatic allografts are selected based on donor demographics, medical history, and the transplant surgeon's assessment of organ quality during procurement. Quality is assessed based on macroscopic appearance, which is biased by individual experience and personal skills. Therefore, we aim to assess the histopathological quality of unallocated pancreas organs to determine how many unallocated organs are potentially of suitable quality for PTx. METHODS AND ANALYSIS: This is a multicenter cross-sectional explorative study. The demographic data and medical history of donor and cause of rejection of the allocation of graft will be recorded. Organs of included donors will be explanted and macroscopic features such as weight, color, size, and stiffness will be recorded by 2 independent transplant surgeons. A tissue sample of the organ will be fixed for further microscopic assessments. Histopathologic assessments will be performed as soon as a biopsy can be obtained. We will evaluate up to 100 pancreata in this study. RESULT: This study will evaluate the histopathological quality of unallocated pancreas organs from brain-dead donors to determine how many of these unallocated organs were potentially suitable for transplantation based on a histopathologic evaluation of organ quality. CONCLUSION: The comprehensive findings of this study could help to increase the pancreas graft pool, overcome organ shortage, reduce the waiting time, and also increase the number of PTx in the future. Registration number: ClinicalTrials.gov: NCT04127266
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spelling pubmed-74786402020-09-24 Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant) Kulu, Yakup Khajeh, Elias Ghamarnejad, Omid Nikdad, Mohammadsadegh Sabagh, Mohammadsadegh Ali-Hasan-Al-Saegh, Sadeq Nadalin, Silvio Quante, Markus Pisarski, Przemyslaw Jänigen, Bernd Reißfelder, Christoph Mieth, Markus Morath, Christian Goeppert, Benjamin Schirmacher, Peter Strobel, Oliver Hackert, Thilo Zeier, Martin Springel, Rainer Schleicher, Christina Büchler, Markus W. Mehrabi, Arianeb Medicine (Baltimore) 7100 BACKGROUND: Pancreas graft quality directly affects morbidity and mortality rates after pancreas transplantation (PTx). The criteria for pancreas graft allocation are restricted, which has decreased the number of available organs. Suitable pancreatic allografts are selected based on donor demographics, medical history, and the transplant surgeon's assessment of organ quality during procurement. Quality is assessed based on macroscopic appearance, which is biased by individual experience and personal skills. Therefore, we aim to assess the histopathological quality of unallocated pancreas organs to determine how many unallocated organs are potentially of suitable quality for PTx. METHODS AND ANALYSIS: This is a multicenter cross-sectional explorative study. The demographic data and medical history of donor and cause of rejection of the allocation of graft will be recorded. Organs of included donors will be explanted and macroscopic features such as weight, color, size, and stiffness will be recorded by 2 independent transplant surgeons. A tissue sample of the organ will be fixed for further microscopic assessments. Histopathologic assessments will be performed as soon as a biopsy can be obtained. We will evaluate up to 100 pancreata in this study. RESULT: This study will evaluate the histopathological quality of unallocated pancreas organs from brain-dead donors to determine how many of these unallocated organs were potentially suitable for transplantation based on a histopathologic evaluation of organ quality. CONCLUSION: The comprehensive findings of this study could help to increase the pancreas graft pool, overcome organ shortage, reduce the waiting time, and also increase the number of PTx in the future. Registration number: ClinicalTrials.gov: NCT04127266 Wolters Kluwer Health 2020-03-06 /pmc/articles/PMC7478640/ /pubmed/32150070 http://dx.doi.org/10.1097/MD.0000000000019335 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle 7100
Kulu, Yakup
Khajeh, Elias
Ghamarnejad, Omid
Nikdad, Mohammadsadegh
Sabagh, Mohammadsadegh
Ali-Hasan-Al-Saegh, Sadeq
Nadalin, Silvio
Quante, Markus
Pisarski, Przemyslaw
Jänigen, Bernd
Reißfelder, Christoph
Mieth, Markus
Morath, Christian
Goeppert, Benjamin
Schirmacher, Peter
Strobel, Oliver
Hackert, Thilo
Zeier, Martin
Springel, Rainer
Schleicher, Christina
Büchler, Markus W.
Mehrabi, Arianeb
Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title_full Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title_fullStr Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title_full_unstemmed Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title_short Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant)
title_sort expanding pancreas donor pool by evaluation of unallocated organs after brain death: study protocol clinical trial (spirit compliant)
topic 7100
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478640/
https://www.ncbi.nlm.nih.gov/pubmed/32150070
http://dx.doi.org/10.1097/MD.0000000000019335
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