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Expanding Pancreas Donor Pool by Evaluation of Unallocated Organs After Brain Death - The EXPLORE Study

NCT04127266 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-12-23

No results posted yet for this study

Summary

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.

Conditions

  • Unallocated Pancreas Organs

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • University of Freiburg

    collaborator OTHER

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • German Organ Transplantation Foundation

    collaborator UNKNOWN

  • Dr. A. Mehrabi

    lead OTHER

Principal Investigators

  • Arianeb Mehrabi, MD · Department of General, Visceral and Transplant Surgery, University Hospital

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-07-01
Completion
2022-11-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04127266 on ClinicalTrials.gov