Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

What Was Tested

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

Their hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.

It had two arms (groups): Octreotide (experimental) and no octreotide (other).

No Octreotide.

The registry classes the interventions as drug and other.

More on the Plan

Inclusion Criteria: Duodenal or ampullary adenoma greater than or equal to 10mm.

Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 18 years up to 89 years.

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

How the Study Was Run

Design: randomized, single-group and open-label.

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.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-03 with completion listed for 2018-06-28.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Post endoscopic mucosal resection bleeding (time frame: 3 days).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 33 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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