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Open Access Clinical trial protocol

Extended pancreas donor program – the EXPAND study rationale and study protocol

Andrea Proneth1, Andreas A Schnitzbauer12, Florian Zeman3, Johanna R Foerster1, Ines Holub1, Helmut Arbogast4, Wolf O Bechstein2, Thomas Becker5, Carsten Dietz6, Markus Guba4, Michael Heise7, Sven Jonas8, Stephan Kersting9, Jürgen Klempnauer10, Steffen Manekeller11, Volker Müller12, Silvio Nadalin13, Björn Nashan14, Andreas Pascher15, Falk Rauchfuss16, Michael A Ströhlein17, Peter Schemmer18, Peter Schenker19, Stefan Thorban20, Thomas Vogel21, Axel O Rahmel22, Richard Viebahn19, Bernhard Banas23, Edward K Geissler1, Hans J Schlitt1 and Stefan A Farkas1*

Author Affiliations

1 Department of Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany

2 Department of General and Visceral Surgery, Goethe-University Hospital and Clinics, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany

3 Centre for Clinical Studies, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany

4 Ludwig Maximilian's University, Department of Surgery, University Hospital Grosshadern, Marchioninistrasse 15, 81377 Munich, Germany

5 Department of General and Thoracic Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Strasse 3, 24105 Kiel, Germany

6 Department of Visceral, Thoracic and Vascular Surgery, University Hospital Marburg, Baldingerstrasse, 35043 Marburg, Germany

7 Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany

8 Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig, Liebigstrasse 20, 04103 Leipzig, Germany

9 Department of General, Thoracic and Vascular Surgery, University of Dresden, Fetscherstrasse 74, 01307 Dresden, Germany

10 Visceral and Transplantation Surgery, Hannover Medical School, General, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany

11 Department of Surgery, University Hospital Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn, Germany

12 Department of Surgery, University Hospital Erlangen, Krankenhausstrasse 12, 91054 Erlangen, Germany

13 Department of General, Visceral and Transplant Surgery, University Hospital Tübingen, Hoppe-Seyler-Str. 3, 72076 Tübingen, Germany

14 Department of Hepatobiliary Surgery and Visceral Transplantation, University Medical Center Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany

15 Department of General, Visceral and Transplantation Surgery, Charité-University Medicine Berlin, Augustenburger Platz 1, 13353 Berlin, Germany

16 Department of General, Visceral and Vascular Surgery, University Hospital Jena, Erlanger Allee 101, 07747 Jena, Germany

17 Cologne-Merheim Medical Center, Department of Abdominal, Vascular, and Transplant Surgery, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109 Cologne, Germany

18 Clinic for General, Visceral and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

19 Department of Surgery, Knappschafts-Hospital, Ruhr-University Bochum, In der Schornau 23-25, 44892 Bochum, Germany

20 Klinikum Rechts der Isar, Department of Surgery, Technical University of Munich, Ismaninger Strasse 22, 81675 Munich, Germany

21 Department of General Surgery, University Hospital of Muenster, Albert-Schweitzer-Campus 1, 48149 Muenster, Germany

22 Eurotransplant International Foundation, 2301CH, Leiden, The Netherlands

23 Department of Internal Medicine II, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany

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Transplantation Research 2013, 2:12  doi:10.1186/2047-1440-2-12

Published: 1 July 2013

Abstract

Background

Simultaneous pancreas kidney transplantation (SPK), pancreas transplantation alone (PTA) or pancreas transplantation after kidney (PAK) are the only curative treatment options for patients with type 1 (juvenile) diabetes mellitus with or without impaired renal function. Unfortunately, transplant waiting lists for this indication are increasing because the current organ acceptability criteria are restrictive; morbidity and mortality significantly increase with time on the waitlist. Currently, only pancreas organs from donors younger than 50 years of age and with a body mass index (BMI) less than 30 are allocated for transplantation in the Eurotransplant (ET) area. To address this issue we designed a study to increase the available donor pool for these patients.

Methods/Design

This study is a prospective, multicenter (20 German centers), single blinded, non-randomized, two armed trial comparing outcome after SPK, PTA or PAK between organs with the currently allowed donor criteria versus selected organs from donors with extended criteria. Extended donor criteria are defined as organs procured from donors with a BMI of 30 to 34 or a donor age between 50 and 60 years. Immunosuppression is generally standardized using induction therapy with Myfortic, tacrolimus and low dose steroids. In principle, all patients on the waitlist for primary SPK, PTA or PAK are eligible for the clinical trial when they consent to possibly receiving an extended donor criteria organ. Patients receiving an organ meeting the current standard criteria for pancreas allocation (control arm) are compared to those receiving extended criteria organ (study arm); patients are blinded for a follow-up period of one year. The combined primary endpoint is survival of the pancreas allograft and pancreas allograft function after three months, as an early relevant outcome parameter for pancreas transplantation.

Discussion

The EXPAND Study has been initiated to investigate the hypothesis that locally allocated extended criteria organs can be transplanted with similar results compared to the currently allowed standard ET organ allocation. If our study shows a favorable comparison to standard organ allocation criteria, the morbidity and mortality for patients waiting for transplantation could be reduced in the future.

Trial registration

Trial registered at: NCT01384006

Keywords:
Pancreas transplantation; Organ allocation; Extended donor criteria; Rejection