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

Abstract

BackgroundSimultaneous 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/DesignThis 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.DiscussionThe 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 registrationTrial registered at: NCT01384006

Guidelines for the assessment and acceptance of potential brain-dead organ donors

“…A major trial, the EXPAND study (Extended Pancreas Donor Program), which is currently underway, was designed to assess extended criteria for the donation and acceptance of pancreases and to compare the related morbidity and mortality to those associated with presently used criteria (A) . ( 241 )…”

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“…Results of this study are eagerly awaited. 10 Until then, retrospective analyses such as this study are the best estimation of results obtained after transplant of rescue organs as defined by the Eurotransplant region. An additional limitation may be the small sample size, which is not suited to allow conclusions for all patients, especially not outside the Eurotransplant region.…”

“…[6][7][8][9] Use of pancreatic offers from nonstandard or extended criteria donors should be reconsidered. 9,10 Because of the possibility of using these organs for transplant, the so called "rescue allocation" strategy was introduced in the Eurotransplant region in the early 2000s.…”

Pancreas transplantation: a treatment option for people with diabetes

“…Although steatotic organs often provide good immediate function if transplanted, they are liable to severe reperfusion pancreatitis with substantial associated morbidity ; for this reason, fatty organs are usually discarded. For the same reason, in the UK, donors with a BMI > 30 kg/m 2 are declined for solid organ donation, although the evidence base for this rationale is limited . An objective approach to donor risk factors has been carried out by Axelrod et al .…”