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

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.

Study Overview

• Status: Completed
• Conditions: Cholangiopancreatography, Endoscopic Retrograde
• Intervention / Treatment: Procedure: Intraductal secretin test (IDST)

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evan L Fogel, MD; Phone Number: 317-944-2816; Email: efogel@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ERCP with inadvertent pancreatic cannulation; Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol.

Procedure: Intraductal secretin test (IDST); If pancreatic duct entry incidentally occurs during the clinically scheduled ERCP and the pancreatic duct appears normal, an IDST will be performed for study purposes. An IDST consists of the administration of human secretin, after which pancreatic juice is collected intraductally. In this study, the fluid will be collected through continuous aspiration in 5 minute intervals for 30 minutes. Samples will be collected at 5, 10, 15, 20, 25, and 30 minutes after secretin administration (6 collections in total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	5 minutes
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	10 minutes
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	15 minutes
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	20 minutes
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	25 minutes
Secretory flow rates measured by volume	Volume of pancreatic juices will be collected	30 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	5 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	10 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	15 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	20 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	25 minutes
Bicarbonate concentration of timed pancreatic juice	Concentration of bicarbonate levels will be determined	30 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Secretin
• Other Study ID Numbers: 1203008365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No