Simultaneous pancreas-kidney transplants Surgery
Conditions
Interventions
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 k
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of perfused pancreases transplanted (organ utilisation), measured at the time of the operation 2. Proportion of patients with pancreas graft intra-vascular thrombosis (detected on CT scan, day 2-10 post-op) requiring anticoagulation during inpatient stay 3. Proportion of patients with early kidney graft loss, defined as surgical removal of the kidney during the 3-month follow-up period 4. Proportion of patients with post-transplantation graft pancreatitis, defined as evidence of pancreatitis on contrast-enhanced CT scan of the abdomen (performed between day 2 and 10 post-op). 5. Proportion of patients with at least one clinically suspected & treated episode of acute rejection of pancreas graft during the 3-month follow-up period 6. Patient survival at 90 days estimated using the Kaplan-Meier method 7. Median length of hospital and ICU stay postoperatively (a surrogate marker for burden of postoperative complications) 8. Proportion of patients with ureteric, bowel, and vascular complications during the 3-month follow-up period 9. Median number of interventions per patient (surgical/endoscopic/radiological) in the first 30 days after transplantation 10. Proportion of patients with at least one re-admission during the 3-month follow-up period 11. Proportion of patients with at least one infection (defined as a clinically diagnosed and treated infection) during the 3-month follow-up period 12. Mean change in full blood count, serum glucose, serum C-reactive protein (CRP), serum amylase and lipase during inpatient stay. Mean change will be estimated using linear regression. 13. Mean/median full blood count, serum glucose, serum C-reactive protein (CRP), serum amylase and lipase at 1-month and 3-month follow-up visits 14. Mean change in blood glucose (point-of-care) during inpatient stay. Mean change will be estimated using linear regression 15. Mean change in drain amylase (when available) during inpatient stay. Mean change will be estimated using linear re | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Hunter
Outcome results
None listed