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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: Secretin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02869893

CIN_MRCPStudy_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subjects between the ages of 6 and 15.9 years.
2. Subjects without a documented history of (or suggestive of) pancreatic disease

Exclusion criteria

1. 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).
2. Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI).
3. Subjects who require any form of sedation or general anesthesia for MRI.
4. Subjects unable to breath-hold for the required 15-20 second imaging sequence.
5. Subjects who are pregnant or less than 12 months post-partum.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

Healthy Participants

Other group

Description:

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

Treatment:

Drug: Secretin