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Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients

Plain-language guide to NCT01094561: not phased interventional trial of Secretin, 23 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01094561
Phase
not phased
Status
completed
Start
2006-07
Completion (planned or actual)
2015-02
Participants
23 (actual)
Design
na, open label (everyone knows who gets what), diagnostic
Conditions studied
Pancreatic Cancer
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Secretin.

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

Single arm (open label).

The registry classes the interventions as drug and procedure.

More on the Plan

Traditional radiological methods lack the resolution to detect early lesions.

Magnetic resonance cholangiopancreatography (MRCP) has emerged as a widely-accepted alternative with comparable sensitivity to ERCP.

The researchers will recruit 25 patients for a prospective pilot study examining S-MRCP as a screening technique in high-risk individuals.

All recruited patients will undergo S-MRCP in conjunction with magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), as well as secretin-enhanced EUS (S-EUS).

Who Took Part

The registry lists 23 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18 years of age and older.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: any contraindication to mri, including but not limited to implanted metal devices (e.g. pacemaker,berry aneurysm clips, neural stimulator or cochlear implants); known pancreatic malignancy or dysplasia; history of sensitivity to secretin.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Secretin study did not mask who received what.

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

It started in 2006-07 with completion listed for 2015-02.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: S-MRCP and S-EUS Concordance (time frame: Day 1 and up to 30 days after S-MRCP).

It also tracked 1 secondary outcome, for example The Positive Predictive Value of S-MRCP.

What This Means in Plain Language

Put simply, this is a not phased trial of Secretin in 23 people.

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

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.

Our Notes on the Compound

Secretin: A 27-amino-acid gut hormone that triggers pancreatic secretion; used as a diagnostic agent in pancreatic function testing.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.