Cholangiopancreatography, Endoscopic Retrograde
Conditions
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.
Interventions
PROCEDUREIntraductal 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).
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secretory flow rates measured by volume | 5 minutes | Volume of pancreatic juices will be collected |
| Bicarbonate concentration of timed pancreatic juice | 5 minutes | Concentration of bicarbonate levels will be determined |
Countries
United States
Outcome results
None listed