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

Primary Purpose

Graft Pancreatitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Two-Layer Method pancreas preservation system
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Pancreatitis focused on measuring Pancreas transplantation, graft pancreatitis, Two-layer method, organ preservation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Post-transplantation adverse event frequency
Post-transplantation adverse event frequency (graft thrombosis, hemorrhage, peri-pancreatic abscess, re-laparotomy, cadaver duodenum leak, pseudo-aneurysm formation, rejection, graft failure, patient death)

Secondary Outcome Measures

Standard post-transplantation morbidity endpoints
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.

Full Information

First Posted
December 17, 2007
Last Updated
August 8, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00592280
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Logistic problems with adequately timely organ collection and transport
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Pancreatitis
Keywords
Pancreas transplantation, graft pancreatitis, Two-layer method, organ preservation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Two-Layer Method pancreas preservation system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-transplantation adverse event frequency
Description
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
Secondary Outcome Measure Information:
Title
Standard post-transplantation morbidity endpoints
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Brian Stevens, MD, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11003355
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.
Results Reference
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PubMed Identifier
12431575
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.
Results Reference
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Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation

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