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

Tracking Information

First Received Date ^ICMJE

December 17, 2007

Last Updated Date

December 27, 2007

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00592280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Open Label, Historical Control, Single Group Assignment, Safety Study

Condition ^ICMJE

Graft Pancreatitis

Intervention ^ICMJE

Device: Two-Layer Method pancreas preservation system

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00592280

Responsible Party

R. Brian Stevens, MD, PhD Director Kidney and Pancreas Transplantation Program, University of Nebraska Medical Center, Department of Surgery

Study ID Numbers ^ICMJE

UNMC IRB # 047-07-FB, IDE G060082

Study Sponsor ^ICMJE

University of Nebraska

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

R Brian Stevens, MD, PhD

University of Nebraska

Information Provided By

University of Nebraska

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP