Clinical trial NCT03263481: Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?
Official title: Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Secretory flow rates measured by volume
timeFrame: 5 minutes
measure: Secretory flow rates measured by volume
timeFrame: 10 minutes
measure: Secretory flow rates measured by volume
timeFrame: 15 minutes
measure: Secretory flow rates measured by volume
timeFrame: 20 minutes
measure: Secretory flow rates measured by volume
timeFrame: 25 minutes
measure: Secretory flow rates measured by volume
timeFrame: 30 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 5 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 10 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 15 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 20 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 25 minutes
measure: Bicarbonate concentration of timed pancreatic juice
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Evan L Fogel, MD
role: PRINCIPAL_INVESTIGATOR
References: