Current partner codePEPTIDESDE
NCT03263481·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

8

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

PROCEDURE

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).

Timeline

From registration to results.

  1. First posted

    Aug 28, 2017

  2. Study start

    Sep 1, 2017

  3. Primary completion

    Sep 1, 2023

  4. Study completion

    Sep 1, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Sep 22, 2023

Outcomes

What the study measures.

Primary outcomes

Secretory flow rates measured by volume

Time frame · 5 minutes

Volume of pancreatic juices will be collected

Secretory flow rates measured by volume

Time frame · 10 minutes

Volume of pancreatic juices will be collected

Secretory flow rates measured by volume

Time frame · 15 minutes

Volume of pancreatic juices will be collected

Secretory flow rates measured by volume

Time frame · 20 minutes

Volume of pancreatic juices will be collected

Secretory flow rates measured by volume

Time frame · 25 minutes

Volume of pancreatic juices will be collected

Secretory flow rates measured by volume

Time frame · 30 minutes

Volume of pancreatic juices will be collected

Bicarbonate concentration of timed pancreatic juice

Time frame · 5 minutes

Concentration of bicarbonate levels will be determined

Bicarbonate concentration of timed pancreatic juice

Time frame · 10 minutes

Concentration of bicarbonate levels will be determined

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Indiana University

Indianapolis, Indiana, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.