MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics

What Was Tested

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

It had 1 arm (groups): Healthy Participants (other).

MRCP with Secretin and MR elastography will be performed on all participants.

The registry classes the interventions as drug.

More on the Plan

Introduction/Methods: Pancreatic fibrosis is the end stage of chronic pancreatitis (CP), which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic insufficiency (PI).

PI has serious negative implications on a child's growth and health but, if diagnosed early, PI can be treated, minimizing the detrimental effects of PI.

Currently, direct pancreatic function testing (PFT) via collection of pancreatic fluid is the "gold standard" for diagnosis of PI but it is an invasive testing that may require sedation or general anesthesia.

Magnetic resonance cholangiopancreatography (MRCP) with secretin administration (MR-PFT) and MR elastography (MRE) may allow non-invasive, and potentially early diagnosis of CP and PI.

Who Took Part

Enrollment: 57 actual participants took part.

It was open to people of any sex aged from 6 years up to 15 years.

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

Examples of who could join: Subjects between the ages of 6 and 15.9 years.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: subjects who require any form of sedation or general anesthesia for mri; subjects unable to breath-hold for the required 15-20 second imaging sequence; subjects who are pregnant or less than 12 months post-partum.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

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

It started in 2016-08-10 with completion listed for 2017-04-06.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Total Secreted Fluid Volume as Measured by MR-PFT (time frame: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)).

It also tracked 2 secondary outcomes, for example Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE) and Volumetric Measurement of Pancreatic Parenchymal Volume.

What This Means in Plain Language

Put simply, this is a not phased trial of Secretin in 57 people.

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

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