The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection

What Was Tested

The trial (phase 3) is built around Somatostatin.

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of velocity and blood flow of the hepatic circulation in patients undergoing liver resection.

The patients will be randomized in two groups: the study group will receive somatostatin and the control group will receive the placebo.

In both groups, patients will undergo hepatectomy and directly postoperatively they will receive either somatostatin or placebo, depending on their randomization.

It had two arms (groups): Study group (active comparator) and Control group (placebo comparator).

The study group includes participants who will receive somatostatin postoperatively (after liver resection).

The registry classes the interventions as drug.

More on the Plan

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of blood flow of the portal circulation at patients who have undergone hepatectomy.

The patients will be randomized in two groups, namely the group that will receive somatostatin (study group) and the group that will receive the placebo (control group).

The following data will also be recorded: platelets, bilirubin (total and direct), albumin, cholesterol, urea, International Normalized Ratio, sodium, Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, Alkaline Phosphatase, gamma-Glutamyl Transferase and the Model for End-stage Liver Disease score of each patient will be calculated.

Finally, their patients will undergo a Computer Tomography scan in order to measure their liver and spleen volumetry.

Who Took Part

The registry lists 40 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). Patients whose indication for hepatectomy will be decided by a multidisciplinary team meeting. Patients who eill agree to sign an informed consent.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: patients who do not meet the inclusion criteria and those; patients undergoing synchronous hepatectomy-colectomy.

How the Study Was Run

Design: randomized, parallel-group and single-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.

In this single-blind Somatostatin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2019-08-01 with completion listed for 2020-03-31.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: The effect of somatostatin in the regulation of velocity of the hepatic circulation at patients who have undergone hepatectomy (time frame: 7 days). The effect of somatostatin in the regulation of diameter of the vessels of the hepatic circulation at patients who have undergone hepatectomy (time frame: 7 days). The effect of somatostatin in the regulation of blood flow of the hepatic circulation at patients who have undergone hepatectomy (time frame: 7 days).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Somatostatin in 40 people.

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

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