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Secretin in Ex-situ Liver Perfusion
Sponsor: Erasmus Medical Center
Summary
The main objective is to assess whether the use of human synthetic secretin in a clinical (COR-)NMP procedure can restore physiological HCO3- content of the bile during ex-situ NMP.
Official title: Secretin Therapy During Ex-Situ Normothermic Liver Machine Perfusion: A Critical Factor for Restoration of Bile Duct Physiology and the Protective "Bicarbonate Umbrella"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04-26
Completion Date
2026-10
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
Secretin administration during ex-situ liver machine perfusion
In at least 20 cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming (COR) for 60 minutes (DHOPE-COR-NMP) livers, the investigators will add 16mcg of synthetic human secretin to the perfusate at the start of COR phase of the protocol and a second dose of 16mcg during the NMP phase after the decision moment whether to transplant or not. This number was chosen based on an average acceptance rate of 70%, and therefore would generate 14 transplanted livers while 6 livers are expected not to be transplanted (not passing the standard viability criteria). As the acceptance rate is subject to fluctuations over time (due to variations in the quality of donor offers), the investigators want to include at least 14 transplanted livers and 6 livers that are not transplanted (not passing the standard viability criteria), in order to have the best representative situation. When both numbers are reached, inclusions will stop.
Locations (1)
Erasmus Medical Center
Rotterdam, South Holland, Netherlands