Unallocated Pancreas Organs Clinical Trial
Official title:
Expanding Pancreas Donor Pool by Evaluation of Unallocated Organs After Brain Death: The EXPLORE Study
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, the aim of this study is to
assess the histopathological quality of unallocated pancreas organs to determine how many
unallocated organs are of suitable quality for PTx, based on histopathologic evaluations. The
reasons for allocation rejection will be reported and the correlation between cause of
allocation rejection and histopathological quality of the allocated organ will be evaluated.
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. A tissue sample of the organ will be fixed for further
microscopic assessments. Histopathologic assessments will be reported 6 hours (or at time of
organ delivery if later than 6 hours), 9 hours, 12 hours, 15 hours, and 18 hours after
procurement. 100 pancreases will be evaluated in this study.
With advances in surgery and immunosuppressive therapy, PTx has become an accepted and
standardized therapeutic surgery worldwide. Today, PTx is a promising treatment for type 1
diabetes mellitus and for patients undergoing total pancreatectomy because of benign disease.
It has been demonstrated that PTx can provide a good glycemic control and insulin
independence and improve diabetic lesions including retinopathy, nephropathy, neuropathy, and
vasculopathy. Furthermore, thanks to improved immunosuppressive agents, prophylaxis against
infections and thrombosis, and modifications in surgical approaches, outcomes after whole
organ PTx has consistently improved over the past 20 years. The 1- and 5-year patient
survival rates after PTx are approximately 95% and 85%, respectively, and the 1-, and 5-year
graft survival rates are 90%, and 70%, respectively.
Morbidity and mortality still occurs after PTx. Morbidity and mortality rates after PTx are
mainly related to pancreas graft quality. To decrease these, some restricted criteria for
pancreas graft allocation have been defined. However, these allocation criteria have
decreased the overall availability of pancreas organs. Consequently, despite an increase in
organs from deceased donors, organ utilization (20% of all potential donor pancreases are
ultimately used for whole organ transplantation) and also PTx rates (10% overall decline)
have decreased. In the US, only 13% of deceased donors provide a pancreas that is utilized
for transplantation. Data from Eurotransplant indicate that only 27% of donor pancreases are
transplanted, either as whole pancreas grafts or as islet grafts. In addition to the
restricted pancreas allocation criteria, some allocated/offered organs are not accepted by
transplant surgeons (which is biased by individual experience and personal skills) after an
organ quality assessment.
Longer waiting lists, increased waiting times, and donor shortages have increased the need
for and number of extended donor criteria organs that are accepted for transplantation. To
date, the most important selection criteria to identify suitable pancreatic allografts are
donor demographics, donor medical history (age, gender, cause of death, etc.), and the
transplant surgeon's own organ quality assessment based on macroscopic appearance. However,
it is unclear, whether unallocated organs have a poor histopathologic quality for
transplantation. To the best of our knowledge, no systematic histopathologic quality
assessment of unallocated pancreas grafts has been performed, so far. In this study, for the
first time, the histopathological quality of unallocated pancreas organs from brain-dead
donors will be assessed to determine the number of unallocated organs that were potentially
suitable for transplantation.
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