Extended Pancreas Donor Program – The EXPAND Study A prospective multicenter trial testing the use of pancreas donors over age 50

AbstractBackgroundPancreas 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 or BMI 30-34kg/m2).MethodsUtilization of EDC organs required the implementation of a new allocation system within Eurotransplant. The study was a prospective, multicenter, two-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.Results79 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. 1-year pancreas survival was 83.3% and 83.5% in the EDC versus standard group. 1-year kidney allograft survival was approximately 94% in both groups. Rejection episodes and morbidity were similar.ConclusionEXPAND shows in a prospective trial that selected EDC organs of donors aged >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. 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 or BMI 30-34kg/m2). Methods Utilization of EDC organs required the implementation of a new allocation system within Eurotransplant. The study was a prospective, multicenter, two-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 79 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. 1-year pancreas survival was 83.3% and 83.5% in the EDC versus standard group. 1-year kidney allograft survival was approximately 94% in both groups. Rejection episodes and morbidity were similar. Conclusion EXPAND shows in a prospective trial that selected EDC organs of donors aged >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. Corresponding author: Dr. Andrea Proneth, University Hospital Freiburg, Department of Surgery, Hugstetter Str. 55, 79106 Freiburg, Germany, e-mail: andrea.proneth@uniklinik-freiburg.de Trial registration: Trial registered at http://ift.tt/PmpYKN NCT01384006 Competing interests: A.P.'s 1, 16 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. FR received travel grants and speaker's bureau from Novartis, Roche, Biotest and Astellas. All other authors declare that they have no competing interests. The study was sponsored by the University Hospital Regensburg and was supported by research grants from Astellas and Novartis. Authors' contributions: A.P.1, 16 and S.A.F initiated, designed and coordinated the study. A.P.1, 16 collected an interpreted data for analysis, managed medical monitoring and wrote the first manuscript 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.3, A. W., H.A., S.M., S.N., M.H., M.A.S., B.B., P.S.11,15, T.B., W.O.B., A.P.13, 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 manuscript. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

http://ift.tt/2nLakyP