Current partner codePEPTIDESDE
NCT02869893·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

57

Locations

1

Results

Posted

Publications

12

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

DRUG

Secretin

Timeline

From registration to results.

  1. First posted

    Aug 17, 2016

  2. Study start

    Aug 10, 2016

  3. Primary completion

    Apr 6, 2017

  4. Study completion

    Apr 6, 2017

  5. Results posted

    Aug 7, 2020

  6. Registry updated

    Aug 7, 2020

Outcomes

What the study measures.

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)

Time frame · Single time point, pre-secretin

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.

Volumetric Measurement of Pancreatic Parenchymal Volume

Time frame · Single time point, pre-secretin

Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI)

Eligibility

Who can take part.

Minimum age
6 Years
Maximum age
15 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Publications

Results and literature.

PMID 23357924Amann 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.PMID 25556020Schwarzenberg 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.PMID 25310479Somaraju 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.PMID 24840042Arya 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.PMID 15017490Conwell 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.PMID 25630864Abu 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.PMID 22228105Pelley 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.PMID 26001927Sendler 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.PMID 15842594Conwell 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.PMID 17387611Conwell 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.PMID 20110743Zuccaro 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.PMID 26465953Sainani 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.

Primary links

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