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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP with inadvertent pancreatic cannulation | Experimental | Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraductal secretin test (IDST) | 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). |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Evan L Fogel, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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|
| 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 |