Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation

Study Overview
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Brief Summary
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Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance. For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution has been increasingly used for abdominal organ procurement. Retrospective reports published so far have demonstrated the safety of both perfusion solutions. However, to date, no prospective study comparing both perfusion solutions has been published. Aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with HTK vs. UW solution. The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement in clinical pancreas transplantation.

Official Title
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A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation

Conditions
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Diabetes Mellitus, Pancreas Transplantation

Intervention / Treatment
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* Other: Organ perfusion during pancreas procurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: brain dead, heart beating organ donor donor age 10 - 50 years donor body mass index < 30kg/m2 pancreas cold ischemia time < 20 hours written informed consent of the pancreas recipient Exclusion Criteria: missing written consent pancreas retransplantation recipient participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>In situ organ perfusion using HTK solution during pancreas procurement | Other: Organ perfusion during pancreas procurement<br>* Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement<br>|
| Active Comparator: 2<br>In situ perfusion using UW solution during pancreas procurement | Other: Organ perfusion during pancreas procurement<br>* Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreas graft survival |  | 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum amylase |  | 6 months after transplantation | 
| Serum lipase |  | 6 months after transplantation | 
| C-peptide |  | 6 months after transplantation | 
| HbA1c |  | 6 months after transplantation | 
| Exogenous insulin requirement |  | 6 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas Clinical, Donor, Pancreas Clinical, Preservation Solutions, Organ Preservation and Procurement, Surgery, Organ Procurement, Ischemia reperfusion Injury, Organ Preservation and Procurement