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

• Sponsor: Indiana University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03263481
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Sep 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Secretory flow rates measured by volume [5 minutes]

   Volume of pancreatic juices will be collected

2. Secretory flow rates measured by volume [10 minutes]

   Volume of pancreatic juices will be collected

3. Secretory flow rates measured by volume [15 minutes]

   Volume of pancreatic juices will be collected

4. Secretory flow rates measured by volume [20 minutes]

   Volume of pancreatic juices will be collected

5. Secretory flow rates measured by volume [25 minutes]

   Volume of pancreatic juices will be collected

6. Secretory flow rates measured by volume [30 minutes]

   Volume of pancreatic juices will be collected

7. Bicarbonate concentration of timed pancreatic juice [5 minutes]

   Concentration of bicarbonate levels will be determined

8. Bicarbonate concentration of timed pancreatic juice [10 minutes]

   Concentration of bicarbonate levels will be determined

9. Bicarbonate concentration of timed pancreatic juice [15 minutes]

   Concentration of bicarbonate levels will be determined

10. Bicarbonate concentration of timed pancreatic juice [20 minutes]

    Concentration of bicarbonate levels will be determined

11. Bicarbonate concentration of timed pancreatic juice [25 minutes]

    Concentration of bicarbonate levels will be determined

12. Bicarbonate concentration of timed pancreatic juice [30 minutes]

    Concentration of bicarbonate levels will be determined

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Evan L Fogel, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evan Fogel, Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT03263481
• Other Study ID Numbers: 1203008365
• First Posted: Aug 28, 2017
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• 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: Secretin

Study Results

No Results Posted as of Aug 19, 2022