Secretin in Ex-situ Liver Perfusion

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Secretin.

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.

It had two arms (groups): Historical control group (no intervention) and Secretin administration during liver machine perfusion (COR-NMP) (experimental).

Historical cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming for 60 minutes (DHOPE-COR-NMP) livers that did not receive synthetic human secretin during the perfusion.

The registry classes the interventions as drug.

More on the Plan

Liver transplantation is the only curative treatment option for patients with end-stage liver disease, but it is limited by a large gap between the number of patients in need and donor organs available.

Similar or even higher discard rates are observed in other countries, such as the US.

Machine perfusion (MP) is a dynamic, isolated platform to preserve liver grafts out-of-the-body by circulation of an oxygenated perfusate.

While dual hypothermic oxygenated perfusion (DHOPE) reconditions the graft in a hypometabolic state, normothermic MP (NMP) allows full assessment of metabolic function at physiological temperatures.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (\>18 years old). Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: multiorgan transplantation; split liver transplant; living donor liver transplantation.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Secretin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-04-26 with completion listed for 2026-06.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cholangiocellular viability assessment - Biliary Bicarbonate (time frame: Periprocedural).

It also tracked 1 secondary outcome, for example Cholangiocellular viability assessment - Bile production.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Secretin in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.