Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

What Was Tested

This registered phase 4 trial tested Octreotide.

It had two arms (groups): 24-hour octreotide infusion (experimental) and 72-hour octreotide infusion (active comparator).

Patients will receive octreotide infusion over 24 hours.

Patients will receive octreotide infusion over 72 hours.

The registry classes the interventions as drug.

More on the Plan

In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.

This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.

Who Took Part

34 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: Adult males and females who are 18 years of age or older. Evidence or suspicion of upper gastrointestinal bleed (GIB). Patient with known or suspected cirrhosis. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: known upper gastrointestinal malignancy; bleeding from gastric varices, with or without esophageal varices; use of any other endoscopic method to stop gi bleeding beyond endoscopic band ligation.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: outcomes assessor.

It started in 2018-09-19 with completion listed for 2024-12-01.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed (time frame: 72 hours).

It also tracked 2 secondary outcomes, for example Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed and Survival at 7 Days and 30 Days After Control of Initial Bleed.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 34 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.