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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholangiopancreatography, Endoscopic Retrograde

Intervention / Treatment
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* Procedure: Intraductal secretin test (IDST)


Participation Criteria
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Eligibility Criteria
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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: Pregnant woman or breast feeding Age <18 years Patient unable to give informed consent Patient with a history of pancreatic surgery Patient with a history of pancreatic cancer Patient with a history of acute or chronic pancreatitis Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or EUS Patient with a current or prior history of average daily alcohol consumption of greater than 60 g per day for more than 2 years Patient with a history of cigarette smoking greater that 20 pack-years Patient with a history of pancreas divisum Evidence of chronic pancreatitis on pancreatogram during ERCP 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. History of allergy or adverse reactions to secretin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP with inadvertent pancreatic cannulation<br>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)<br>* 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).<br>|

What is the study measuring?
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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 |