Pancreatic Perfusion Using Secretin and MRI

What Was Tested

This registered phase 1, phase 2 trial tested Secretin.

The purpose of this study is to assess pancreatic perfusion in patients with chronic pancreatitis at rest and after secretin stimulation and compare this to published data on pancreatic perfusion in normal subjects.

It had 1 arm (groups): Secretin (experimental).

The registry classes the interventions as drug.

More on the Plan

Pancreatic blood flow or perfusion is difficult to quantify due to the complex vascular supply to the organ and its retroperitoneal location, adjacent to the abdominal aorta.

Identifying changes in flow in all these vessels with good spatial and temporal resolution is challenging but important in understanding many of the chronic conditions of the pancreas.

Chronic pancreatitis (CP) is an inflammatory condition of the pancreas leading to irreversible damage to the tissue.

However the mechanisms of chronic and post-prandial pain for CP patients are not well understood, but tissue ischaemia, inflammation and neurological changes have been proposed.

Who Took Part

Enrollment: 15 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Adults with chronic pancreatitis (as defined by the Cambridge criteria).

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: allergy to secretin; refusal to consent for the study; MRI contraindications e.g. pacemaker, artificial heart valve.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Secretin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2012-06 with completion listed for 2016-04.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Blood flow to pancreas as measured by arterial spin labelling MRI (time frame: 1.5 hours).

It also tracked 3 secondary outcomes, for example Change in blood flow to pancreas after intravenous secretin, Pancreatic diffusion and Pancreatic volume.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Secretin in 15 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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