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

NCT ID: NCT02869893

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2017-04-06

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Participants

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

Group Type: OTHER

Secretin

Intervention Type: DRUG

Interventions

Secretin

Intervention Type: DRUG

Other Intervention Names

ChiRhoStim

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ChiRhoClin, Inc.

INDUSTRY

Sponsor Role: collaborator

The National Pancreas Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maisam Abu-El-Haija, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Andrew Trout, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

Amann ST, Yadav D, Barmada MM, O'Connell M, Kennard ED, Anderson M, Baillie J, Sherman S, Romagnuolo J, Hawes RH, Alkaade S, Brand RE, Lewis MD, Gardner TB, Gelrud A, Money ME, Banks PA, Slivka A, Whitcomb DC. Physical and mental quality of life in chronic pancreatitis: a case-control study from the North American Pancreatitis Study 2 cohort. Pancreas. 2013 Mar;42(2):293-300. doi: 10.1097/MPA.0b013e31826532e7.

Reference Type: BACKGROUND

PMID: 23357924 (View on PubMed)

Schwarzenberg SJ, Bellin M, Husain SZ, Ahuja M, Barth B, Davis H, Durie PR, Fishman DS, Freedman SD, Gariepy CE, Giefer MJ, Gonska T, Heyman MB, Himes R, Kumar S, Morinville VD, Lowe ME, Nuehring NE, Ooi CY, Pohl JF, Troendle D, Werlin SL, Wilschanski M, Yen E, Uc A. Pediatric chronic pancreatitis is associated with genetic risk factors and substantial disease burden. J Pediatr. 2015 Apr;166(4):890-896.e1. doi: 10.1016/j.jpeds.2014.11.019. Epub 2014 Dec 30.

Reference Type: BACKGROUND

PMID: 25556020 (View on PubMed)

Somaraju UR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2014 Oct 13;(10):CD008227. doi: 10.1002/14651858.CD008227.pub2.

Reference Type: BACKGROUND

PMID: 25310479 (View on PubMed)

Arya VB, Senniappan S, Demirbilek H, Alam S, Flanagan SE, Ellard S, Hussain K. Pancreatic endocrine and exocrine function in children following near-total pancreatectomy for diffuse congenital hyperinsulinism. PLoS One. 2014 May 19;9(5):e98054. doi: 10.1371/journal.pone.0098054. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24840042 (View on PubMed)

Conwell DL, Zuccaro G Jr, Vargo JJ, Morrow JB, Obuchowski N, Dumot JA, Trolli PA, Burton A, O'laughlin C, Van Lente F. An endoscopic pancreatic function test with cholecystokinin-octapeptide for the diagnosis of chronic pancreatitis. Clin Gastroenterol Hepatol. 2003 May;1(3):189-94. doi: 10.1053/cgh.2003.50028.

Reference Type: BACKGROUND

PMID: 15017490 (View on PubMed)

Abu Dayyeh BK, Conwell D, Buttar NS, Kadilaya V, Hart PA, Baumann NA, Bick BL, Chari ST, Chowdhary S, Clain JE, Gleeson FC, Lee LS, Levy MJ, Pearson RK, Petersen BT, Rajan E, Steen H, Suleiman S, Banks PA, Vege SS, Topazian M. Pancreatic juice prostaglandin e2 concentrations are elevated in chronic pancreatitis and improve detection of early disease. Clin Transl Gastroenterol. 2015 Jan 29;6(1):e72. doi: 10.1038/ctg.2014.23.

Reference Type: BACKGROUND

PMID: 25630864 (View on PubMed)

Pelley JR, Gordon SR, Gardner TB. Abnormal duodenal [HCO3-] following secretin stimulation develops sooner than endocrine insufficiency in minimal change chronic pancreatitis. Pancreas. 2012 Apr;41(3):481-4. doi: 10.1097/MPA.0b013e31823a4c33.

Reference Type: BACKGROUND

PMID: 22228105 (View on PubMed)

Sendler M, Beyer G, Mahajan UM, Kauschke V, Maertin S, Schurmann C, Homuth G, Volker U, Volzke H, Halangk W, Wartmann T, Weiss FU, Hegyi P, Lerch MM, Mayerle J. Complement Component 5 Mediates Development of Fibrosis, via Activation of Stellate Cells, in 2 Mouse Models of Chronic Pancreatitis. Gastroenterology. 2015 Sep;149(3):765-76.e10. doi: 10.1053/j.gastro.2015.05.012. Epub 2015 May 19.

Reference Type: BACKGROUND

PMID: 26001927 (View on PubMed)

Conwell DL, Zuccaro G, Purich E, Fein S, Vanlente F, Vargo J, Dumot J, O'laughlin C, Trolli P. The effect of moderate sedation on exocrine pancreas function in normal healthy subjects: a prospective, randomized, cross-over trial using the synthetic porcine secretin stimulated Endoscopic Pancreatic Function Test (ePFT). Am J Gastroenterol. 2005 May;100(5):1161-6. doi: 10.1111/j.1572-0241.2005.41386.x.

Reference Type: BACKGROUND

PMID: 15842594 (View on PubMed)

Conwell DL, Zuccaro G, Purich E, Fein S, Vargo JJ, Dumot JA, VanLente F, Lopez R, Trolli P. Comparison of endoscopic ultrasound chronic pancreatitis criteria to the endoscopic secretin-stimulated pancreatic function test. Dig Dis Sci. 2007 May;52(5):1206-10. doi: 10.1007/s10620-006-9469-6. Epub 2007 Mar 27.

Reference Type: BACKGROUND

PMID: 17387611 (View on PubMed)

Zuccaro P, Stevens T, Repas K, Diamond R, Lopez R, Wu B, Conwell DL. Magnetic resonance cholangiopancreatography reports in the evaluation of chronic pancreatitis: a need for quality improvement. Pancreatology. 2009;9(6):764-9. doi: 10.1159/000201304. Epub 2010 Jan 21.

Reference Type: BACKGROUND

PMID: 20110743 (View on PubMed)

Sainani NI, Kadiyala V, Mortele K, Lee L, Suleiman S, Rosenblum J, Wang W, Banks PA, Conwell DL. Evaluation of Qualitative Magnetic Resonance Imaging Features for Diagnosis of Chronic Pancreatitis. Pancreas. 2015 Nov;44(8):1280-9. doi: 10.1097/MPA.0000000000000466.

Reference Type: BACKGROUND

PMID: 26465953 (View on PubMed)

Balci NC, Smith A, Momtahen AJ, Alkaade S, Fattahi R, Tariq S, Burton F. MRI and S-MRCP findings in patients with suspected chronic pancreatitis: correlation with endoscopic pancreatic function testing (ePFT). J Magn Reson Imaging. 2010 Mar;31(3):601-6. doi: 10.1002/jmri.22085.

Reference Type: BACKGROUND

PMID: 20187202 (View on PubMed)

Shi Y, Glaser KJ, Venkatesh SK, Ben-Abraham EI, Ehman RL. Feasibility of using 3D MR elastography to determine pancreatic stiffness in healthy volunteers. J Magn Reson Imaging. 2015 Feb;41(2):369-75. doi: 10.1002/jmri.24572. Epub 2014 Feb 5.

Reference Type: BACKGROUND

PMID: 24497052 (View on PubMed)

Itoh Y, Takehara Y, Kawase T, Terashima K, Ohkawa Y, Hirose Y, Koda A, Hyodo N, Ushio T, Hirai Y, Yoshizawa N, Yamashita S, Nasu H, Ohishi N, Sakahara H. Feasibility of magnetic resonance elastography for the pancreas at 3T. J Magn Reson Imaging. 2016 Feb;43(2):384-90. doi: 10.1002/jmri.24995. Epub 2015 Jul 7.

Reference Type: BACKGROUND

PMID: 26149267 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CIN_MRCPStudy_001

Identifier Type: -

Identifier Source: org_study_id