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

Not Applicable

Completed

• Conditions: Cholangiopancreatography, Endoscopic Retrograde
• Interventions: Procedure: Intraductal secretin test (IDST)

• Registration Number: NCT03263481
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Study Start: 2017-09-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERCP with inadvertent pancreatic cannulation	Intraductal secretin test (IDST)	Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol.

Primary Outcome Measures

Name	Time	Method
Secretory flow rates measured by volume	30 minutes	Volume of pancreatic juices will be collected
Bicarbonate concentration of timed pancreatic juice	30 minutes	Concentration of bicarbonate levels will be determined

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States