Hypothermic oxygenated pancreas perfusion - the HOPP study

ISRCTN	ISRCTN94113651
DOI	https://doi.org/10.1186/ISRCTN94113651
Integrated Research Application System (IRAS)	334198
Central Portfolio Management System (CPMS)	61042
Sponsor	University of Oxford
Funder	National Institute for Health and Care Research

Submission date: 23/02/2026
Registration date: 02/03/2026
Last edited: 02/03/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Pancreas transplantation is an effective treatment for patients with the most 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 icebox. This simple method slows down cell activity and reduces the need for oxygen and energy. Recent clinical trials in kidney and liver transplantation have shown that continuously pumping the organ with cold preservation fluid enriched with oxygen provides improved protection and better clinical outcomes. This technique has increased donor organ utilisation (defined as the proportion of organs donated that result in a transplant) but has not been tested in pancreas transplantation. This study will investigate the application of the above-mentioned technique in pancreas transplantation.

Who can participate?
Patients aged 18 years and over who are receiving a simultaneous pancreas and kidney transplant in Oxford

What does the study involve?
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 the pancreas and kidney, post-transplant complications (particularly any inflammation of the pancreas), the need for additional surgery, and the length of hospital stay.

What are the possible benefits and risks of participating?
This research has the potential to reduce injury to the donor pancreas, increasing the number of pancreases safely and successfully used for transplant.

Where is the study run from?
The study is run by NHS Blood and Transplant Clinical Trials Unit and the University of Oxford (UK)

When is the study starting and how long is it expected to run for?
March 2026 to December 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
HOPP@nhsbt.nhs.uk

Contact information

Prof James Hunter
Scientific, Public, Principal investigator

Nuffield Department of Surgical Sciences
Nuffield Department of Surgery
Level 6
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865381037
Email	HOPP@nhsbt.nhs.uk

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Historical
Assignment	Single
Purpose	Treatment
Scientific title	Oxygenated hypothermic machine perfusion in pancreas preservation for transplantation, a Phase I safety and feasibility trial
Study acronym	HOPP
Study objectives
Ethics approval(s)	Approved 27/01/2026, North West - Greater Manchester South Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; Not provided; gmsouth.rec@hra.nhs.uk), ref: 25/NW/0256
Health condition(s) or problem(s) studied	Simultaneous pancreas-kidney transplants
Intervention	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.
Intervention type	Device
Phase	Phase I
Drug / device / biological / vaccine name(s)	VitaSmart
Primary outcome measure(s)	Safety and feasibility of end-ischaemic HMPO2 of pancreas grafts prior to transplantation in clinical practice, measured using pancreas graft survival, defined as the absence of insulin requirement at 90 days postoperatively
Key secondary outcome measure(s)	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 regression 16. Mean/median* glycated haemoglobin (HbA1C) at 90 days. 17. Proportion of patients with normal, impaired glucose tolerance or diabetic oral glucose tolerance test (OGTT) results at discharge and at 90 days (These categories are normal if fasting is under 6 mmol/L and at 2 hours is under 7.8 mmol/L, impaired glucose tolerance if fasting is 6.0 to 6.9 mmol/L and at 2 hours is 7.9 to 11.0 mmol/L, or diabetic if fasting is over or equal to 7.0 mmol/L and/or at 2 hours is over or equal to 11.1 mmol/l) 18. Proportion of patients with 90-day graft loss related to transplant intravascular thrombosis 19. Proportion of patients with delayed kidney graft function (DGF), defined as the need for dialysis in the first week after transplantation 20. Proportion of patients with acute kidney rejection in the first 90 days after transplantation, defined as an episode of rejection (Banff 1a or greater) confirmed by graft biopsy 21. Mean/median* serum creatinine at 90 days 22. Kidney graft function, defined as mean estimated glomerular filtration rate (eGFR) at 90 days in ml/min/1.73 m² using the CKD-EPI formula 23. During HMPO2 the following will be recorded to explore possible viability markers. As this is novel data, only available for the HMPO2 group, a range of descriptive statistics and plots will be used to explore the data over time. 23.1. Perfusate flow in the circuit as recorded by the investigator 23.2. Pancreatic resistance as recorded by the investigator 23.3. Proportion of pancreases with no oedema, mild, moderate and severe oedema using macroscopic oedema scale 23.4. Markers of damage in the perfusate measured at 15-minute intervals during perfusion: 23.4.1. Amylase 23.4.2. Lipase 23.4.3. Cell-free DNA (cfDNA)
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	23/03/2026
Date of final enrolment	30/09/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Churchill Hospital

Old Road
Headington
Oxford
OX3 7LE
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

24/02/2026: Study's existence confirmed by the North West - Greater Manchester South Research Ethics Committee.