Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Graft Pancreatitis	Device: Two-Layer Method pancreas preservation system	Phase I

MedlinePlus related topics:

Pancreas Transplantation

ChemIDplus related topics:

Pancrelipase Ultrase Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Historical Control, Single Group Assignment, Safety Study

Official Title:	Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Post-transplantation adverse event frequency (graft thrombosis, hemorrhage, peri-pancreatic abscess, re-laparotomy, cadaver duodenum leak, pseudo-aneurysm formation, rejection, graft failure, patient death) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	34
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

Device: Two-Layer Method pancreas preservation system

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.

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

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592280

Locations


United States, Nebraska
	The Nebraska Medical Center
	Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

Investigators


Principal Investigator:	R Brian Stevens, MD, PhD	University of Nebraska

More Information

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.

Responsible Party:	University of Nebraska Medical Center, Department of Surgery ( R. Brian Stevens, MD, PhD Director Kidney and Pancreas Transplantation Program )
Study ID Numbers:	UNMC IRB # 047-07-FB, IDE G060082
First Received:	December 17, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00592280
Health Authority:	United States: Food and Drug Administration