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Pancreatic Perfusion Using Secretin and MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT02458118

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Contact: John Simpson

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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   
Principal Investigator: Dileep Lobo, PhD         
Sub-Investigator: Damian Bragg, MBChB         
Sub-Investigator: Sue Francis, PhD         
Sponsors and Collaborators
University of Nottingham
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Principal Investigator: John Simpson University of Nottingham

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Responsible Party: University of Nottingham Identifier: NCT02458118    
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:
Blood flow
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs