Extended pancreas donor program – the EXPAND study rationale and study protocol View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-12

AUTHORS

Andrea Proneth, Andreas A Schnitzbauer, Florian Zeman, Johanna R Foerster, Ines Holub, Helmut Arbogast, Wolf O Bechstein, Thomas Becker, Carsten Dietz, Markus Guba, Michael Heise, Sven Jonas, Stephan Kersting, Jürgen Klempnauer, Steffen Manekeller, Volker Müller, Silvio Nadalin, Björn Nashan, Andreas Pascher, Falk Rauchfuss, Michael A Ströhlein, Peter Schemmer, Peter Schenker, Stefan Thorban, Thomas Vogel, Axel O Rahmel, Richard Viebahn, Bernhard Banas, Edward K Geissler, Hans J Schlitt, Stefan A Farkas

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. More... »

PAGES

12

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/2047-1440-2-12

DOI

http://dx.doi.org/10.1186/2047-1440-2-12

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1019982137

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23816330


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411 Department of General and Visceral Surgery, Goethe-University Hospital and Clinics, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany
412 Department of Internal Medicine II, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany
413 Department of Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany
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415 https://www.grid.ac/institutes/grid.412468.d schema:alternateName University Hospital Schleswig-Holstein
416 schema:name Department of General and Thoracic Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Strasse 3, 24105, Kiel, Germany
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418 https://www.grid.ac/institutes/grid.412581.b schema:alternateName Witten/Herdecke University
419 schema:name Cologne-Merheim Medical Center, Department of Abdominal, Vascular, and Transplant Surgery, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109, Cologne, Germany
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421 https://www.grid.ac/institutes/grid.418969.b schema:alternateName Eurotransplant
422 schema:name Eurotransplant International Foundation, 2301CH, Leiden, The Netherlands
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424 https://www.grid.ac/institutes/grid.4488.0 schema:alternateName TU Dresden
425 schema:name Department of General, Thoracic and Vascular Surgery, University of Dresden, Fetscherstrasse 74, 01307, Dresden, Germany
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427 https://www.grid.ac/institutes/grid.5253.1 schema:alternateName University Hospital Heidelberg
428 schema:name Clinic for General, Visceral and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany
429 rdf:type schema:Organization
430 https://www.grid.ac/institutes/grid.5570.7 schema:alternateName Ruhr University Bochum
431 schema:name Department of Surgery, Knappschafts-Hospital, Ruhr-University Bochum, In der Schornau 23-25, 44892, Bochum, Germany
432 rdf:type schema:Organization
433 https://www.grid.ac/institutes/grid.5802.f schema:alternateName Johannes Gutenberg University of Mainz
434 schema:name Department of General, Visceral and Transplantation Surgery, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, 55131, Mainz, Germany
435 rdf:type schema:Organization
436 https://www.grid.ac/institutes/grid.6363.0 schema:alternateName Charité
437 schema:name Department of General, Visceral and Transplantation Surgery, Charité-University Medicine Berlin, Augustenburger Platz 1, 13353, Berlin, Germany
438 rdf:type schema:Organization
 




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