EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding

What Was Tested

In this phase 4 trial, researchers set out to test Somatostatin and Terlipressin.

Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage.

It had two arms (groups): EVL + vasoconstrictor (active comparator) and EVL + PPI (experimental).

The registry classes the interventions as drug.

More on the Plan

Thus, the researchers designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus somatostatin infusion or losec infusion for 5 days.

Who Took Part

The registry lists 118 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: The etiology of portal hypertension is cirrhosis. Age ranges between 18-80 y/o. EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: association with severe systemic illness, such as sepsis, copd, uremia; association with gastric variceal bleeding; failure in the control of bleeding by emergency evl.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2006-12 with completion listed for 2010-04.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Success rate of initial hemostasis (time frame: 5 days). very early rebleeding (time frame: 48-120 hours after treatment).

It also tracked 3 secondary outcomes, for example The amount of blood transfusion within 42 days, Mortality and The size and number of ulcers on varices.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Somatostatin and Terlipressin in 118 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 and the Terlipressin compound page, all human trials.