Graft Pancreatitis
Conditions
Keywords
Pancreas transplantation, graft pancreatitis, Two-layer method, organ preservation
Brief summary
The purpose of this project is to compare the effect of oxygenated preservation of the pancreas before transplantation using the Two-Layer Method (TLM) against outcomes previously experienced with organs preserved using only standard University of Wisconsin (UW) storage solution. It is our hypothesis that TLM preservation will reduce the frequency and severity of complications of pancreas transplantation, increase the number of organs acceptable for transplantation, and spare individual patients and their families suffering and hardship.
Detailed description
Two-Layer Method (TLM) preservation consists of a storage chamber containing a layer of highly oxygenated, water-immiscible liquid perfluorocarbon (perfluorodecalin, C10F18) surmounted by a layer of conventional UW (or similar) organ preservation solution. The perfluorocarbon is sufficiently dense (\ 2 g/ml) that the pancreas floats on top of it, in contact with both layers. The perfluorocarbon combines low toxicity with an oxygen content 75 times greater than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury. In animal models of pancreas ischemic and storage injury, TLM preservation has been strikingly successful at improving the outcome of both islet isolation and pancreas transplantation.
Interventions
DRUGTwo-Layer Method pancreas preservation system drug
Preserving the pancreas before transplantation in an oxygenated system containing highly oxygenated liquid perfluorocarbon (perfluorodecalin, C10F18. The perfluorocarbon combines low toxicity with a capacity to dissolve 75 times more oxygen than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury.
DEVICETwo-Layer Method pancreas preservation system device
Preserving the pancreas before transplantation in an oxygenated system containing highly oxygenated liquid perfluorocarbon (perfluorodecalin, C10F18. The perfluorocarbon combines low toxicity with a capacity to dissolve 75 times more oxygen than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury.
Sponsors
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Listed for pancreas transplantation at the University of Nebraska Medical Center
Exclusion criteria
* Ineligibility for medical/surgical/psychosocial reasons for listing for pancreas transplantation at the University of Nebraska Medical Center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-transplantation adverse event frequency | 1 year | Post-transplantation adverse event frequency (graft thrombosis, hemorrhage, peri-pancreatic abscess, re-laparotomy, cadaver duodenum leak, pseudo-aneurysm formation, rejection, graft failure, patient death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard post-transplantation morbidity endpoints | 1 year | Standard post-transplantation morbidity endpoints including fungal, bacterial, and viral infections, and incidence and rate of stroke and heart attack. Length of hospital stay and re-admission and re-operation rates will also be monitored. |
Countries
United States
Outcome results
None listed