Oxygenated Hypothermic Machine Perfusion in Pancreas Preservation for Transplantation, a phase 1 safety and feasibility trial (HOPP)

Research summary

Pancreas transplantation is an effective treatment for patients with severe complications of diabetes. It improves quality-of-life and life-expectancy by returning blood sugar levels to normal and removing the need for insulin. Most pancreas transplants are performed at the same time as a kidney transplant for patients with kidney failure due to diabetes. When a donor pancreas is removed from the body it is stored in specialist fluid in an ice box. This method slows down cell activity reducing, but not eliminating, the need for oxygen and energy. Recent trials in kidney and liver transplantation have shown that continuously pumping the organ with cold preservation fluid enriched with oxygen provides improved preservation and better clinical outcomes. This technique has increased donor organ utilisation (defined as the proportion of organs surgically removed from donors which result in a transplant) but this technology has not been tested clinically in pancreas transplantation, whilst showing promise in a laboratory setting. This study will investigate the application of this technique in pancreas transplantation. HOPP 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 in an ice box, as standard. While the kidney is being transplanted, the pancreas will be pumped with oxygenated fluid for 2 hours (+/- 30 mins). 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 function and survival of both pancreas and kidney transplants, post-transplant complications (particularly any inflammation of the pancreas), the need for additional surgery and duration of hospital stay, as well as relevant blood test results.

Principal Investigator

Prof James Hunter

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

334198