Expanding pancreas donor pool by evaluation of unallocated organs after brain death: Study protocol clinical trial (SPIRIT Compliant).
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
Mar 2020
Mar 2020
Historique:
entrez:
10
3
2020
pubmed:
10
3
2020
medline:
17
3
2020
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
METHODS
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
RESULTS
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
CONCLUSIONS
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.
Identifiants
pubmed: 32150070
doi: 10.1097/MD.0000000000019335
pii: 00005792-202003060-00026
pmc: PMC7478640
doi:
Banques de données
ClinicalTrials.gov
['NCT04127266']
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e19335Références
Am J Transplant. 2010 Apr;10(4 Pt 2):961-72
pubmed: 20420646
Eur Surg Res. 2015;54(1-2):24-33
pubmed: 25300930
Asian J Surg. 2016 Apr;39(2):66-73
pubmed: 26216260
Clin Transplant. 2019 Mar;33(3):e13481
pubmed: 30659654
Transplantation. 2018 Aug;102(8):1330-1337
pubmed: 29406443
Am J Transplant. 2017 Jan;17 Suppl 1:117-173
pubmed: 28052606
Clin Transplant. 2011 May-Jun;25(3):E225-32
pubmed: 21362050
Clin Transplant. 2009 Dec;23 Suppl 21:115-20
pubmed: 19930324
Pancreas. 2014 Nov;43(8):1190-3
pubmed: 25333402
Diabetes Obes Metab. 2006 Jan;8(1):1-7
pubmed: 16367876
Am J Transplant. 2015 Sep;15(9):2475-82
pubmed: 25989187
Transplant Proc. 2008 Jun;40(5):1275-8
pubmed: 18589086
Transpl Int. 2011 Jul;24(7):733-57
pubmed: 21668528
Am J Transplant. 2007;7(5 Pt 2):1359-75
pubmed: 17428285
Transplant Res. 2013 Jul 01;2(1):12
pubmed: 23816330
Adv Chronic Kidney Dis. 2009 Jul;16(4):278-87
pubmed: 19576558
BMC Health Serv Res. 2014 Nov 25;14:584
pubmed: 25421753
Nephrol Dial Transplant. 2013 May;28(5):1315-22
pubmed: 23512107
Am J Transplant. 2009 Apr;9(4 Pt 2):894-906
pubmed: 19341414
J Gastrointest Surg. 2007 Feb;11(2):209-16
pubmed: 17390175
BMC Surg. 2013 Oct 23;13:47
pubmed: 24152541
Am J Transplant. 2017 Dec;17(12):3159-3171
pubmed: 28792681
HPB (Oxford). 2009 Sep;11(6):469-75
pubmed: 19816610
Clin Transplant. 2006;20 Suppl 17:44-50
pubmed: 17100700
Am J Transplant. 2007 Jun;7(6):1561-71
pubmed: 17511681
Am J Transplant. 2016 Sep;16(9):2556-62
pubmed: 27232750
Ann Transplant. 2019 Jul 26;24:439-445
pubmed: 31346153
Acta Chir Belg. 2008 Nov-Dec;108(6):673-8
pubmed: 19241916
Transplant Proc. 2005 Mar;37(2):1265-7
pubmed: 15848690
Transplantation. 2013 May 15;95(9):1134-41
pubmed: 23435455
World J Transplant. 2018 Nov 30;8(7):237-251
pubmed: 30596031