Clinical trial NCT00592280: Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation
Official title: Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Graft Pancreatitis
Keywords: Pancreas transplantation
graft pancreatitis
Two-layer method
organ preservation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Post-transplantation adverse event frequency
timeFrame: 1 year
Secondary outcomes:
measure: Standard post-transplantation morbidity endpoints
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: R Brian Stevens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/00007890-200009150-00010.
citation: 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. doi: 10.1016/s0041-1345(02)03376-6. No abstract available.