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

This study has been terminated.
(Logistic problems with adequately timely organ collection and transport)
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00592280
First received: December 17, 2007
Last updated: April 16, 2010
Last verified: April 2010
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation

Resource links provided by NLM:


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 ]

Enrollment: 7
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: R. Brian Stevens, MD, PhD Director Kidney and Pancreas Transplantation Program, University of Nebraska Medical Center, Department of Surgery
ClinicalTrials.gov Identifier: NCT00592280     History of Changes
Other Study ID Numbers: 047-07-FB, IDE G060082
Study First Received: December 17, 2007
Last Updated: April 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
Pancreas transplantation
graft pancreatitis
Two-layer method
organ preservation

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Graft
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014