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Intraductal Secretin Stimulation Test: What Is the Proper Collection Time? (IDST)

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ClinicalTrials.gov Identifier: NCT03263481
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
Evan Fogel, Indiana University

Study Description
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Brief Summary:
The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as determined by a 30 minute intraductal secretin stimulation test in patients with a low likelihood of pancreatic pathology and to compare these data to those obtained from our historical patients with suspected chronic pancreatitis. These will be patients in which inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5 day follow-up phone call. Enrollment goal is 36 subjects.

Condition or disease Intervention/treatment Phase
Cholangiopancreatography, Endoscopic Retrograde Drug: Human Secretin for injection 16 mcg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ERCP with intraductal secretin test
Subjects undergoing ERCP for biliary indication in which inadvertent pancreatic cannulation occurs will receive intraductal secretin testing using a one-time intravenous injection of 16 mcg of human secretin for injection administered over one minute.
 Drug: Human Secretin for injection 16 mcg
Intravenous injection of human secretin for injection (16 mcg) will be administered over one minute. Pancreatic juice will be collected intraductally by continuous aspiration in 5-minute intervals for 30 minutes. Six samples will be collected at 5, 10, 15, 20, 25 and 30 minutes after secretin administration.


Outcome Measures
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Primary Outcome Measures :
  1. Secretory flow rates measured by volume [ Time Frame: 5 minutes ]
    Volume of pancreatic juices will be collected

  2. Secretory flow rates measured by volume [ Time Frame: 10 minutes ]
    Volume of pancreatic juices will be collected

  3. Secretory flow rates measured by volume [ Time Frame: 15 minutes ]
    Volume of pancreatic juices will be collected

  4. Secretory flow rates measured by volume [ Time Frame: 20 minutes ]
    Volume of pancreatic juices will be collected

  5. Secretory flow rates measured by volume [ Time Frame: 25 minutes ]
    Volume of pancreatic juices will be collected

  6. Secretory flow rates measured by volume [ Time Frame: 30 minutes ]
    Volume of pancreatic juices will be collected

  7. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 5 minutes ]
    Concentration of bicarbonate levels will be determined

  8. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 10 minutes ]
    Concentration of bicarbonate levels will be determined

  9. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 15 minutes ]
    Concentration of bicarbonate levels will be determined

  10. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 20 minutes ]
    Concentration of bicarbonate levels will be determined

  11. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 25 minutes ]
    Concentration of bicarbonate levels will be determined

  12. Bicarbonate concentration of timed pancreatic juice [ Time Frame: 30 minutes ]
    Concentration of bicarbonate levels will be determined


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Male or female patients ≥ 18 years of age referred to Indiana University Health, University Hospital for ERCP for a biliary indication, at the discretion of the treating MD (e.g. suspected common bile duct stone, initial post-liver transplant evaluation, suspected or confirmed cholangiocarcinoma, suspected primary sclerosing cholangitis -- see exclusion criterion #12)

Exclusion Criteria:

  1. Pregnant woman or breast feeding
  2. Age <18 years
  3. Patient unable to give informed consent
  4. Patient with a history of pancreatic surgery
  5. Patient with a history of pancreatic cancer
  6. Patient with a history of acute or chronic pancreatitis
  7. Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or EUS
  8. Patient with a current or prior history of average daily alcohol consumption of greater than 60 g per day for more than 2 years
  9. Patient with a history of cigarette smoking greater that 20 pack-years
  10. Patient with a history of pancreas divisum
  11. Evidence of chronic pancreatitis on pancreatogram during ERCP
  12. ERCP for an isolated biliary indication with previous biliary sphincterotomy or for biliary stent exchange, when pancreatic entry should easily be avoided by the endoscopist.
  13. History of allergy or adverse reactions to secretin
Contacts and Locations
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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): NCT03263481


Contacts
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Contact: Evan L Fogel, MD 317-944-2816 efogel@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Evan L Fogel, MD    317-944-2816    efogel@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Evan L Fogel, MD Indiana University
More Information
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Responsible Party: Evan Fogel, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03263481    
Other Study ID Numbers: 1203008365
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Secretin
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs