Glucagon Use in Colonoscopies

What Was Tested

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

The investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

It had two arms (groups): Glucagon (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Glucagon is also routinely administered intravenously for all endoscopic retrograde cholangiopancreatography (ERCP) throughout the United States to facilitate canulation of the duodenal papilla and sphincterotomy.

John Cello in over 5000 ERCP examinations.

The role of glucagon in facilitating colonoscopy remains controversial however and is not considered "routine".

Several studies have evaluated the effect of glucagon on colonoscopy with varying results.

Who Took Part

The registry lists 100 actual participants took part.

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

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

Examples of who could join: Any subject who has already been already cleared for and scheduled to undergo colonoscopy at SFGH endoscopy center.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: refusal to give informed consent; age \<18 or \>70; prior intra-abdominal surgery.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Glucagon study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-04 with completion listed for 2018-05.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Adenoma Detection Rate (ADR) During Colonoscopy Procedure (time frame: During colonoscopy procedure (an average of 1139 seconds for Glucagon Arm and 1353 seconds for Placebo Arm)).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 100 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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