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

NCT ID: NCT03263481

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2023-09-01

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.

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraductal secretin test (IDST)

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Evan Fogel

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan L Fogel, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1203008365

Identifier Type: -

Identifier Source: org_study_id