Trial Using Octreotide to Enhance Liver Recovery After Hepatectomy

What Was Tested

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

This will be a prospective, randomized, double blind trial enrolling patients who will undergo major liver resection.

Patients will be randomized in a 1:1 ratio to receive either octreotide or placebo in the postoperative period.

The patients will receive octreotide intravenously continuously for five days after operation.

It had two arms (groups): Octreotide treatment arm (experimental) and Placebo Arm (placebo comparator).

Octreotide will be administered post-operatively until day 5.

Normal saline will be administered post-operatively until day 5.

The registry classes the interventions as drug and other.

Who Took Part

23 actual participants took part.

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: Age \> 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have acceptable organ and marrow function as defined below:. White Blood Cells \> 2,000/mcL. Absolute Neutrophil Count \> 1,000/mcL.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: patients with known hypersensitivity to octreotide or somatostatin; patients who are receiving any other investigational agents; patients who are taking other medications that prolong qt interval.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2017-07-07 with completion listed for 2020-02-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group.

It also tracked 2 secondary outcomes, for example Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy and Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 23 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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