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

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

— IDST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263481
• Other study ID #: 1203008365
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde

Intervention

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).

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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