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Secretin in Ex-situ Liver Perfusion

NCT07651748 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Liver Transplantation

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Robert J Porte, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-26
Primary Completion
2026-06-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651748 on ClinicalTrials.gov