Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer

What Was Tested

In this not phased trial, researchers set out to test Octreotide.

However, the mechanisms underlying these problems are not well understood.

It had four arms (groups): Esophagectomy (experimental), Total gastrectomy (experimental), Control - no surgery (active comparator) and Pancreaticoduodenectomy (experimental).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Surgical procedure: Two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticodueodenectomy, or matched unoperated healthy controls. At least one year in remission post-resection (surgical groups).

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: pregnancy, breastfeeding; other previous upper gastrointestinal surgery; other disease or medications which may affect satiety gut hormone responses.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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.

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

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

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

It started in 2014-01 with completion listed for 2017-12.

It ran at 2 sites in Ireland (1) and Sweden (1).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Ad libitum calorie intake (time frame: 1 hour).

It also tracked 2 secondary outcomes, for example Post-prandial satiety gut hormone response and Subjective symptom scores.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 20 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 Octreotide compound page, all human trials.