Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Nebraska |
---|---|
Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00592280 |
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 |
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 |
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.
|
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.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
The Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | R Brian Stevens, MD, PhD | University of Nebraska |
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 |
Study First Received: | December 17, 2007 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00592280 |
Health Authority: | United States: Food and Drug Administration |
Pancreas transplantation graft pancreatitis Two-layer method organ preservation |
Digestive System Diseases Benzocaine Pancreatic Diseases Pancrelipase Pancreatitis |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |