Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation
Information source: University of Nebraska
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft Pancreatitis
Intervention: Two-Layer Method pancreas preservation system (Device)
Phase: Phase 1
Status: Enrolling by invitation
Sponsored by: University of Nebraska Official(s) and/or principal investigator(s):
R Brian Stevens, MD, PhD, Principal Investigator, Affiliation: University of Nebraska
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.
Clinical Details
Official title: Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation
Study design: Prevention, Open Label, Historical Control, Single Group Assignment, Safety Study
Primary outcome: 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 outcome: 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.
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
The Nebraska Medical Center, Omaha, Nebraska 68198, United States
Additional Information
Related publications: Matsumoto S, Kandaswamy R, Sutherland DE, Hassoun AA, Hiraoka K, Sageshima J, Shibata S, Tanioka Y, Kuroda Y. Clinical application of the two-layer (University of Wisconsin solution/perfluorochemical plus O2) method of pancreas preservation before transplantation. Transplantation. 2000 Sep 15;70(5):771-4. Hiraoka K, Kuroda Y, Suzuki Y, Fujino Y, Tanioka Y, Matsumoto S, Sakai T, Kandaswamy R, Sutherland DE. Outcomes in clinical pancreas transplantation with the two-layer cold storage method versus simple storage in University of Wisconsin solution. Transplant Proc. 2002 Nov;34(7):2688-9. No abstract available.
Starting date: October 2007
Ending date: August 2011
Last updated: December 27, 2007
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