2010 - TTS International Congress


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International Trends in Organ Donation

147.9 - Extended Pancreas Donor Program - The EXPAND Study

Presenter: Stefan, Farkas, Regensburg, Germany
Authors: Farkas S., Schnitzbauer A., Boerner T., Banas B., Arbogast H., Viebahn R., Schlitt H.

EXTENDED PANCREAS DONOR PROGRAM - THE EXPAND STUDY

INTERNATIONAL TRENDS IN ORGAN DONATION

S.A. Farkas1, A.A. Schnitzbauer1, T. Boerner1, B. Banas2, H. Arbogast3, R. Viebahn4, H.J. Schlitt5
1Surgery, University Clinic of Regensburg, Regensburg/GERMANY, 2Nephrology, University Clinic of Regensburg, Regensburg/GERMANY, 3University Of Munich, Dept. of Surgery - Transplant Surgery, Munich/GERMANY, 4Department Of Surgery, Ruhr University Bochum, Bochum/GERMANY, 5, Univ. Regensburg, Regensburg/GERMANY

Body: Introduction: Although the waiting lists for Simultaneous Pancreas Kidney Transplantation (SPK) and Pancreas Transplantation alone (PTA) are increasing, the number of transplantations are declining in the Eurotransplant (ET) area. One major reason for this decline is the fact that a large number of pancreas allografts, potentially eligible for transplantation are excluded by ET pancreas allocation system (EPAS). Those criteria include an organ-specific cut-off point for donor age >50 years and/or BMI>30. This means that donors that are older than 50 years or donors with a BMI >30 are, at the moment, not allowed to be considered for solid organ transplantation. The pancreas will be directly allocated for islet transplantation. The organ-specific cut-off was once established to provide pancreas for islet transplantation. Methods and Results: We investigated data of all organ donors in Germany in 2008, provided by the german procurement organisation (DSO). The total number of organ donors was 1.198. However, only 510 donors had an age between 3 and 50 years and were thus potentially eligible for pancreas donation. From the 510 donors only 183 (36% of all potential, age restricted pancreas donors) pancreas were removed and 127 (25%) transplanted. Altogether, 676 patients were not even screened for pancreas donation due to age, regardless all other medical conditions. In addition, approximately 13% were not eligible for pancreas donation only due to BMI. Moreover, pancreas in the ET-area are allocated without local priority, leading to longer ischemic times due to transport ways. Although 173 pancreas were allocated and retrieved for islet transplantation, only 17 islet transplantations were performed in the whole ET area in 2008 (ET data). Based on these findings we started a multicenter, prospective, non-randomised feasibility-study, comparing recipients of extended donor criteria-pancreas allografts (SPK or PTA) with patients undergoing SPK or PTA with standard criteria allografts. The so called EXtended PANcreas Donors study, EXPAND), which is conducted in 15 German Transplant Centers. Key inclusion criteria are: brain death, age 50 to 60 or BMI 30-34, CIT ≤8h (only local allocation possible), primary SPK or PTA, P-PASS-score< 17. Allowing a drop-out rate of approximately 10%, a total of 83 patients per treatment arm are required (166 patients in total). Primary objective is pancreas allograft survival at 3 months after transplantation. Secondary key objectives (all after one year) are overall survival, insuline free pancreas allograft survival, overall pancreas and kidney allograft survival. Conclusion: In conclusion these data indicate the requirement for a new allocation system also in the ET area to be able to provide a sufficient number of organs for patients on the waiting list. We therefore suggest a new pancreas allocation system where donors with an age of 50-60 years or a BMI of 30-34 are allocated regionally within a cold ischemic time <8h. To prove the hypothesis that extended pancreas allograft donors can be used safely with equal outcome in recipients a prospective comparative multicenter feasibility-study, the EXPAND Study was started.

Disclosure: All authors have declared no conflicts of interest.


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