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Pancreatic Perfusion Using Secretin and MRI

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ClinicalTrials.gov Identifier: NCT02458118
Recruitment Status : Unknown
Verified February 2016 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : May 29, 2015
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
The purpose of this study is to assess pancreatic perfusion in patients with chronic pancreatitis at rest and after secretin stimulation and compare this to published data on pancreatic perfusion in normal subjects.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Secretin Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis
Study Start Date : June 2012
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Secretin
Secretin 1 IU/kg over 3 min
Drug: Secretin
Secretin 1 IU/kg over 3 min
Other Name: Secrelux" Sanochemia Pharmazeutika AG, Wein, Germany)




Primary Outcome Measures :
  1. Blood flow to pancreas as measured by arterial spin labelling MRI [ Time Frame: 1.5 hours ]

Secondary Outcome Measures :
  1. Change in blood flow to pancreas after intravenous secretin [ Time Frame: 1.5 hours ]
  2. Pancreatic diffusion [ Time Frame: T 0, 5, 10, 20, 30, 40 ]
  3. Pancreatic volume [ Time Frame: T 0, 5, 20, 40 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with chronic pancreatitis (as defined by the Cambridge criteria)

Exclusion Criteria:

  1. Allergy to secretin
  2. Claustraphobia
  3. Refusal to consent for the study
  4. MRI contraindications e.g. pacemaker, artificial heart valve
  5. Previous abdominal surgery except appendectomy or hernia repair
  6. History of chronic abdominal pain from causes other than pancreatitis eg. inflammatory bowel or coeliac disease
  7. Pregnant women (safety concerns from injection of secretin)
  8. Patients younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458118


Contacts
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Contact: John Simpson j.simpson@nottingham.ac.uk

Locations
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United Kingdom
1.5T Brain and Body Imaging centre, University of Nottingham Campus Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
Contact: Eleanor Cox, PhD    0115 9514747    spmmrc@nottingham.ac.uk   
Principal Investigator: Dileep Lobo, PhD         
Sub-Investigator: Damian Bragg, MBChB         
Sub-Investigator: Sue Francis, PhD         
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: John Simpson University of Nottingham

Publications:

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02458118     History of Changes
Other Study ID Numbers: 11109
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
chronic
pancreatitis
secretin
Blood flow
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs