Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

What Was Tested

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

Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points.

To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.

It had two arms (groups): Somatostatin (experimental) and Placebo (placebo comparator).

Patients in this group receive treatment with Somatostatin for 5 days.

Patients in this group receive a placebo for 5 days.

The registry classes the interventions as drug.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Ability and willingness to provide written informed consent. Recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor. Whole liver grafts and partial liver grafts can be included.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: HIV positive patients; patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy; patients included in the preoperative assessment without a csph at the time of the first intraoperative measurement of portal pressure.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

The Somatostatin group and the comparison group ran side by side rather than switching.

As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-12 with completion listed for 2013-12.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example To elucidate pathophysiological pathways in non-cirrhotic grafted livers.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Somatostatin in 33 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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