Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

What Was Tested

The trial (phase 4) is built around Octreotide.

It had two arms (groups): 2 Days of octreotide infusion (experimental) and 5 Days of octreotide infusion (active comparator).

The registry classes the interventions as drug.

More on the Plan

Treatment of variceal bleeding should be started as soon as bleeding is clinically confirmed, regardless the lack of confirmation by upper endoscopy .

Initial therapy should be directed at restoring blood volume.

Vasoactive drug therapy and antibiotic prophylaxis should be initiated as soon as AVB is suspected.

Once AVB is confirmed, vasoactive drug therapy should be administered for five days to avoid early rebleeding.

Who Took Part

The registry lists 184 planned participants were the target.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Acute esophageal varices bleeding.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: initial failure to control variceal bleed on endoscopy; other causes of git bleeding; hepatocellular carcinoma.

How the Study Was Run

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

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: participant.

It started in 2022-06 with completion listed for 2023-06.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Esophageal varices rebleed within 5days after control of initial bleed (time frame: with in 5 days after controlof initial bleeding).

It also tracked 1 secondary outcome, for example Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 184 people.

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

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