A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding

What Was Tested

This registered not phased trial tested Somatostatin.

Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.

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

Emergency EVL plus placebo infusion for 5 days.

The registry classes the interventions as drug.

Who Took Part

61 actual participants took part.

It was open to people of any sex aged from 12 years up to 75 years.

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

Examples of who could join: Clinical diagnosis of portal hypertension. Having hematemesis and/or melena within 24 hour prior to admission. Source of bleeding should be esophageal varices.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: non-cirrhotic cause of portal hypertension; age \<12 or \>75 years; hepatic encephalopathy grade 3 or 4.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Somatostatin 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.

Neither the participants nor the staff measuring them knew who was on Somatostatin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-11 with completion listed for 2009-11.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment failure (time frame: 5 days).

It also tracked 4 secondary outcomes, for example Transfusion requirement, ICU stay in days and Drug-related adverse effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Somatostatin in 61 people.

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.