A Study of Serial Magnetic Resonance Cholangiopancreatography (MRCP) Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers

What Was Tested

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

The sphincter of Oddi is a circular band of muscle which controls the flow of pancreatic juices and bile into the small intestine.

Abnormal function of the Sphincter of Oddi, known as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of abdominal pain.

Making a diagnosis of SOD is difficult and is currently achieved using an invasive pressure test.

It had two arms (groups): Morphine-neostigmine (active comparator) and Secretin (active comparator).

The registry classes the interventions as drug.

More on the Plan

The sphincter of Oddi (SO), which encases the distal common bile duct (CBD) and pancreatic duct (PD), comprises a fibromuscular complex to control the flow of biliary and pancreatic secretions into the duodenum.

Aberrant function of the SO, known as Sphincter of Oddi dysfunction (SOD), can lead to recurrent episodes of biliary or pancreatic type pain.

A number of investigative modalities have been employed in the assessment of SOD.

It is therefore unsurprising that attention has focussed on non-invasive diagnostic tests.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Healthy age matched and sex matched volunteers. No history of chronic abdominal pain. No previous abdominal surgery. No history of regular medication or substance abuse.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: acute illness within preceding 6 weeks; participation in another study within 3 months; allergy to morphine or neostigmine.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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

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

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

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

It started in 2009-01 with completion listed for 2010-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Serum amylase (U/L) (time frame: 0, 60, 120, 180 and 240 minutes). Serum lipase (U/L) (time frame: 0, 60, 120, 180 and 240 minutes). Liver function tests (time frame: 0, 60, 120, 180 and 240 minutes).

It also tracked 4 secondary outcomes, for example Pancreatic duct diameter (mm), Pancreatic duct length (mm), Common bile duct diameter (mm) and Gallbladder volume (mm3).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Secretin in 10 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 Secretin compound page, all human trials.