N/A
N=57
MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02869893 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Total Secreted Fluid Volume as Measured by MR-PFT — 79 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Secretin (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Secreted Fluid Volume as Measured by MR-PFT |
79 | — |
| SECONDARY Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE) |
1.7 | — |
| SECONDARY Volumetric Measurement of Pancreatic Parenchymal Volume |
46 | — |
Summary
The goal of this research study is to learn more about the pancreas. The investigators want to use Magnetic Resonance Cholangiopancreatography (MRCP) to learn more about the size of a normal pancreas. MRCP is a special kind of MRI exam that produces detailed images of the pancreas. The investigators also want to figure out how much fluid the pancreas releases in response to secretin. Secretin is a chemical in the body that causes the pancreas to release fluid that helps with digestion. Secretin is used during the MRCP (MR-PFT) to help identify dysfunction of the pancreas. MR elastography (MRE) will be used to measure how hard the pancreas is. MRE is a special kind of MRI that uses vibrations to image tissue.
Eligibility Criteria
Inclusion Criteria
- Subjects between the ages of 6 and 15.9 years.
- Subjects without a documented history of (or suggestive of) pancreatic disease
Exclusion Criteria
- History of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (IBD), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis).
- Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI).
- 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.
Data sourced from ClinicalTrials.gov (NCT02869893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.