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Extended Pancreas Donor Program—The EXPAND Study

A Prospective Multicenter Trial Testing the Use of Pancreas Donors Older Than 50 Years

Proneth, Andrea, MD1; Schnitzbauer, Andreas A., MD1,2; Schenker, Peter, MD3; Wunsch, Andreas, MD3; Rauchfuss, Falk, MD4; Arbogast, Helmut, MD5; Manekeller, Steffen, MD6; Nadalin, Silvio, MD7; Heise, Michael, MD8; Ströhlein, Michael A., MD9; Banas, Bernhard, MD10; Schemmer, Peter, MD11; Becker, Thomas, MD12; Bechstein, Wolf O., MD2; Pascher, Andreas, MD13; Viebahn, Richard, MD3; Geissler, Edward K., PhD1; Schlitt, Hans J., MD1; Farkas, Stefan A., MD1

doi: 10.1097/TP.0000000000002122
Original Clinical Science—General
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Background Pancreas transplantation is the only curative treatment option for patients with juvenile diabetes. Organ shortage and restrictive allocation criteria are the main reasons for increasing waitlists, leading to severe morbidity and mortality. We designed a study to increase the donor pool with extended donor criteria (EDC) organs (donor age, 50-60 years; body mass index, 30-34 kg/m2).

Methods Utilization of EDC organs required the implementation of a new allocation system within Eurotransplant. The study was a prospective, multicenter, 2-armed trial. The primary endpoint was pancreas function after 3 months. Rejection episodes, kidney function, and waitlist time were secondary endpoints. Patients receiving an EDC organ were study group patients; recipients of standard organs were control group patients. Follow-up was 1 year.

Results Seventy-nine patients were included in 12 German centers, 18 received EDC organs and 61 received standard organs. Recipient demographics were similar. Mean EDC donor age was 51.4 ± 5 years versus 31.7 ± 12 in the control group. Insulin-free graft survival was 83.3% for EDC and 67.2% for standard organs (P = 0.245) after 3 months. One-year pancreas survival was 83.3% and 83.5% in the EDC versus standard group. One-year kidney allograft survival was approximately 94% in both groups. Rejection episodes and morbidity were similar.

Conclusions The Extended Pancreas Donor Program (EXPAND) shows in a prospective trial that selected EDC organs of donors older than 50 years can be used with outcomes similar to standard-criteria organs, therefore showing potential to reduce organ shortage and waiting times. This study substantiates the full implementation of EDC organs in a pancreas allocation system.

The EXPAND prospective trial shows that pancreases from donors aged >50 years can be used for kidney-pancreas transplantation with outcomes similar to standard-criteria organs.

1 Department of Surgery, University Hospital Regensburg, Regensburg, Germany.

2 Department of General and Visceral Surgery, Goethe-University Hospital and Clinics, Frankfurt am Main, Germany.

3 Department of Surgery, University Hospital Knappschaftskrankenhaus Bochum, Ruhr-University Bochum, Bochum, Germany.

4 Department of General, Visceral and Vascular Surgery, University Hospital Jena, Jena, Germany.

5 Department of Surgery, University Hospital Grosshadern, Ludwig Maximilian's University, Munich, Germany.

6 Department of Surgery, University Hospital Bonn, Bonn, Germany.

7 Department of General, Visceral and Transplant Surgery, University Hospital Tübingen, Tübingen, Germany.

8 Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Mainz, Mainz, Germany.

9 Department of Abdominal, Vascular, and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Köln, Germany.

10 Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.

11 Department of General, Visceral and Transplant Surgery, University Hospital of Heidelberg, Heidelberg, Germany.

12 Department of General and Thoracic Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.

13 Department of General, Visceral and Transplantation Surgery, Charité-University Medicine Berlin, Berlin, Germany.

Received 20 August 2017. Revision received 15 December 2017.

Accepted 30 December 2017.

Current address for S.A.F.: Klinik für Allgemein- und Viszeralchirurgie, St. Josefs Hospital Wiesbaden, Beethovenstrasse 20, 65189 Wiesbaden, Germany.

Current address for P.S.: Division of Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036 Graz, Austria.

Current address for A.P.: Department für Chirurgie, Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg, Hugstetter Str. 55, 79106 Freiburg, Germany.

Trial registration: Trial registered at http://www.clinicaltrials.gov: NCT01384006.

The study was sponsored by the University Hospital Regensburg and was supported by research grants from Astellas and Novartis.

A.P.'s institution (University Hospital Regensburg) received a research grant from Astellas and Novartis to support the conduct of the trial. H.J.S. has received lecture honoraria and reimbursement of travel expenses from Novartis, Astellas, Pfizer, and Roche, and also receives research support from Pfizer and Novartis. S.A.F. has received lecture honoraria, reimbursement of travel expenses, and receives research support from Novartis, Astellas, BMS, and Roche. F.R. received travel grants and speaker’s bureau from Novartis, Roche, Biotest, and Astellas.

All other authors declare no conflicts of interest.

A.P. and S.A.F. initiated, designed, and coordinated the study. A.P. collected and interpreted data for analysis, managed medical monitoring, and wrote the first article draft. E.K.G. and R.V. were involved in designing the study and critical data interpretation and analysis. A.A.S. was involved in launching and designing the study, as well as data collection and inclusion of study patients. R.V., P.S., A. W., H.A., S.M., S.N., M.H., M.A.S., B.B., P.S., T.B., W.O.B., A.P., F.R., and H.J.S. were involved in data collection and inclusion of study patients, local ethics approval, and critical intellectual discussion of the manuscript. All authors reviewed and approved the article.

Correspondence: Andrea Proneth, Department of Surgery, University Hospital Freiburg, Hugstetter Str. 55, 79106 Freiburg, Germany. (andrea.proneth@uniklinik-freiburg.de).

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