Department of Surgery, University Hospital Regensburg, Regensburg, Germany.
Department of General and Visceral Surgery, Goethe-University Hospital and Clinics, Frankfurt am Main, Germany.
Transplantation. 2018 Aug;102(8):1330-1337. doi: 10.1097/TP.0000000000002122.
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/m).
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.
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.
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.
胰腺移植是治疗青少年糖尿病患者的唯一根治性治疗方法。器官短缺和限制性分配标准是导致等待名单增加的主要原因，这导致了严重的发病率和死亡率。我们设计了一项研究，旨在通过扩大供体标准（EDC）器官（供体年龄 50-60 岁；体重指数 30-34kg/m）来增加供体库。
在 Eurotransplant 内实施新的分配系统以利用 EDC 器官。该研究是一项前瞻性、多中心、2 臂试验。主要终点是移植后 3 个月的胰腺功能。排斥反应、肾功能和等待名单时间是次要终点。接受 EDC 器官的患者为研究组患者；接受标准器官的患者为对照组患者。随访时间为 1 年。
在 12 个德国中心纳入了 79 例患者，18 例患者接受 EDC 器官，61 例患者接受标准器官。受者的人口统计学特征相似。EDC 供体的平均年龄为 51.4±5 岁，而对照组为 31.7±12 岁。移植后 3 个月时，EDC 的胰岛素-free 移植物存活率为 83.3%，标准器官为 67.2%（P=0.245）。EDC 组和标准组的 1 年胰腺存活率分别为 83.3%和 83.5%。两组 1 年的肾移植物存活率均约为 94%。排斥反应和发病率相似。
前瞻性试验表明，EXPAND 计划中选择的年龄大于 50 岁的 EDC 器官可以与标准器官的结果相似，因此具有减少器官短缺和等待时间的潜力。这项研究证实了在胰腺分配系统中全面实施 EDC 器官。
