Oxygenated hypothermic machine perfusion in pancreas preservation for transplantation, a Phase I safety and feasibility trial
Simultaneous pancreas-kidney transplants
120 minutes of oxygenated hypothermic machine perfusion of the pancreas graft at the end of the cold ischaemia time. The study will recruit 30 patients who are receiving a simultaneous pancreas and kidney transplant in Oxford. The donor organs will be transported from the donor hospital as usual in an icebox. While the kidney is being transplanted, the pancreas will be pumped with oxygenated fluid for 2 hours. The pancreas will then be transplanted as standard. Outcomes in these 30 patients will be compared to 60 recent patients who have had the same type of transplant without pumping of oxygenated fluid. Outcomes will be assessed including the function and survival of both pancreas and kidney, post-transplant complications (particularly any inflammation of the pancreas), the need for additional surgery and the length of hospital stay.
Organ offer (donor liver) criteria: 1. Simultaneous pancreas and kidney from deceased donors, including both Donation after Circulatory Death (DCD) and Donation after Brain Death (DBD) donors 2. Accepted for transplantation according to local criteria 3. Cold ischaemia time (CIT), on arrival to recipient centre, no greater than 10 hours 4. Both donor organs, kidney and pancreas, transported in static cold storage (SCS) prior to the start of oxygenated hypothermic machine perfusion (HMPO2) 5. Donor/family/next of kin consent for research Recipient criteria: 1. Participant is able to give informed consent for participation in the trial 2. Participant has had at least 24 hours to consider written information sent to them 3. 18 years or older 4. On waiting list for simultaneous pancreas-kidney transplantation at Oxford Transplant Centre 5. Able to comply with all study requirements (in the opinion of the investigator or deputy) 6. Fit to proceed with simultaneous pancreas-kidney transplantation
Organ offer (donor liver) criteria: 1. Donor organs accepted for pancreas-only transplants (pancreas after kidney or pancreas transplant alone) 2. Donors subjected to Normothermic Regional Perfusion (NRP) Recipient criteria: 1. Participation in an investigational study likely to affect interpretation of the trial data. 2. Recipients of pancreas-alone or pancreas-after-kidney transplants will be excluded 3. Other significant disease or disorder, which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) affect the participant’s ability to participate in the study