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Clinical Trials/NCT02869893
NCT02869893
Completed
Not Applicable

Magnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in Pediatrics

Children's Hospital Medical Center, Cincinnati1 site in 1 country57 target enrollmentAugust 10, 2016
InterventionsSecretin

Overview

Phase
Not Applicable
Intervention
Secretin
Conditions
Healthy Volunteers
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
57
Locations
1
Primary Endpoint
Total Secreted Fluid Volume as Measured by MR-PFT
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Detailed Description

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). CP and congenital PI affect the pediatric population, and are both increasingly recognized in children. 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. Currently, however, normative data with which to compare MR-PFT and MRE results in pediatric patients with suspected CP/PI is not available. Aims: The investigators propose to determine the normal range for secreted pancreatic fluid volume in response to secretin administration and determine the normal range for pancreatic parenchymal stiffness in a pediatric population that is not affected by pancreatic disease. To date, the investigators have validated their MRCP technique and have successfully performed both MR-PFT and MRE in CP patients; however normative data is essential for validation of our non-invasive technique.

Registry
clinicaltrials.gov
Start Date
August 10, 2016
End Date
April 6, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Healthy Participants

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

Intervention: Secretin

Outcomes

Primary Outcomes

Total Secreted Fluid Volume as Measured by MR-PFT

Time Frame: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)

Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point. A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin.

Secondary Outcomes

  • Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)(Single time point, pre-secretin)
  • Volumetric Measurement of Pancreatic Parenchymal Volume(Single time point, pre-secretin)

Study Sites (1)

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