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

Study 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.

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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Secretin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Participants<br>MRCP with Secretin and MR elastography will be performed on all participants. | Drug: Secretin<br> <br> * Other names: ChiRhoStim;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Secreted Fluid Volume as Measured by MR-PFT | 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. | 35 minutes (20 min pre-secretin, 15 minutes post-secretin) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE) | Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups. | Single time point, pre-secretin | 
| Volumetric Measurement of Pancreatic Parenchymal Volume | Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI) | Single time point, pre-secretin |