Healthy VolunteersNCT02869893
MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics
A study testing Secretin in people with Healthy Volunteers, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Secretin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2016to 6 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects between the ages of 6 and 15.9 years.
- Subjects without a documented history of (or suggestive of) pancreatic disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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
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.
Read the 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
- Being tested
- Secretin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretinDrug
Also called ChiRhoStim
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Other | MRCP with Secretin and MR elastography will be performed on all participants. Receives: Drug: Secretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)
Secondary outcomes (2)
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.
Measured: 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)
Measured: Single time point, pre-secretin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- ChiRhoClin, Inc., The National Pancreas Foundation
- Responsible party
- Sponsor
- Investigators
- Maisam Abu-El-Haija, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiAndrew Trout, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869893
- Sponsor's protocol ID
- CIN_MRCPStudy_001
- Status last verified
- Jul 2020
- First submitted
- 5 Jun 2016
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23357924Schwarzenberg 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.
PubMed 25556020Somaraju 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.
PubMed 25310479Arya 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.
PubMed 24840042Conwell 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.
PubMed 15017490Abu 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.
PubMed 25630864Pelley 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.
PubMed 22228105Sendler 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.
PubMed 26001927Conwell 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.
PubMed 15842594Conwell 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.
PubMed 17387611Zuccaro 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.
PubMed 20110743Sainani 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.
PubMed 26465953Balci 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.
PubMed 20187202Shi 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.
PubMed 24497052Itoh 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.
PubMed 26149267
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02869893
- Acronym / sponsor ID
- CIN_MRCPStudy_001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- ChiRhoClin, Inc., The National Pancreas Foundation
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 7 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Other | Drug: SecretinMRCP with Secretin and MR elastography will be performed on all participants. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects between the ages of 6 and 15.9 years.
- Subjects without a documented history of (or suggestive of) pancreatic disease
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecretinAlso: ChiRhoStim | Drug | Healthy Participants |
Primary outcome
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.
2 secondary outcomes
Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)
Time frame: Single time point, pre-secretin
Volumetric Measurement of Pancreatic Parenchymal Volume
Time frame: Single time point, pre-secretin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Background: PubMed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisam Abu-El-Haija, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Andrew Trout, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secretin in people with Healthy Volunteers, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Secreted Fluid Volume as Measured by MR-PFT (time frame: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869893, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.