Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection

What Was Tested

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

Gastric cancer radical surgery related complications are common.Somatostatin is a conventional medical therapy for bleeding.This study explore the effect of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node dissection.

It had two arms (groups): Somatostatin group (experimental) and Blank group (placebo comparator).

Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.

Use the normal saline instead of somatostatin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 2 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: More than eighteen years old. Gastric cancer diagnosed by pathological examination. Be given informed consent. Without diabetes/hyperthyroidism/Damages of functions of heart, liver and kidney/Systemic Infection/immunodeficiency.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: contraindication of vascular puncture operation; patients who refused to take part in the programe; poor compliance of treatment.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Somatostatin.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2013-01 with completion listed for 2013-07.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: fistula of pancreas (time frame: one year).

It also tracked 3 secondary outcomes, for example amount of bleeding, seroperitoneum and infection of incisional wound.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Somatostatin in 2 people.

Its size is small, so on its own it can only give an early look.

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.