Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices

What Was Tested

This registered not phased trial tested Somatostatin.

The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy.

It had two arms (groups): endoscopic and somatostatin treatment (experimental) and endoscopic therapy (other).

The registry classes the interventions as drug and procedure.

More on the Plan

126 patients will be enrolled in the study, 63 subjects will be randomized into the group A and the other will be into the group B.

Group A: endoscopic therapy and somatostatin treatment.

Who Took Part

126 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Cirrhosis with esophageal gastric varices needed endoscopic therapy. Age 18-75 years. Informed written consent.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: use of vasoactive drugs 24 hours before endoscopic treatment; use of b-blocker within 1 week; previous surgical or endoscopic treatment for esophageal gastric varices.

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.

Only one side, usually the participants, was kept unaware of whether Somatostatin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2011-07 with completion listed for 2012-10.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Portal vein blood flow volume (time frame: change from baseline in portal vein blood flow volume after 7 days treatment).

It also tracked 3 secondary outcomes, for example Portal vein diameter (PVD mm), Mean portal vein blood velocity (PVV cm/s) and Ascites volume.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Somatostatin in 126 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.