The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

What Was Tested

In this not phased trial, researchers set out to test Octreotide for pancreatitis (after the acute phase).

It had four arms (groups): Esophagectomy (experimental), Gastrectomy (experimental), Unoperated healthy control (active comparator) and Pancreaticoduodenectomy (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 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 esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects. Disease-free at least one year post-resection.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: pregnancy, breastfeeding; other previous upper gastrointestinal surgery; unwell or unable to eat.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

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

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2015-03 with completion listed for 2018-03.

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

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Progressive ratio task breakpoint for a sweet-fat reward (time frame: 3 hours).

It also tracked 2 secondary outcomes, for example Number of rewards consumed and Subjective symptom score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide in 40 people with pancreatitis (after the acute phase).

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Pancreatitis (after the acute phase) research.