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Completed

NCT Number: NCT03263481

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

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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Key information

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Secretory flow rates measured by volume

    Time frame: 5 minutes

    Volume of pancreatic juices will be collected

  2. Secretory flow rates measured by volume

    Time frame: 10 minutes

    Volume of pancreatic juices will be collected

  3. Secretory flow rates measured by volume

    Time frame: 15 minutes

    Volume of pancreatic juices will be collected

  4. Secretory flow rates measured by volume

    Time frame: 20 minutes

    Volume of pancreatic juices will be collected

  5. Secretory flow rates measured by volume

    Time frame: 25 minutes

    Volume of pancreatic juices will be collected

  6. Secretory flow rates measured by volume

    Time frame: 30 minutes

    Volume of pancreatic juices will be collected

  7. Bicarbonate concentration of timed pancreatic juice

    Time frame: 5 minutes

    Concentration of bicarbonate levels will be determined

  8. Bicarbonate concentration of timed pancreatic juice

    Time frame: 10 minutes

    Concentration of bicarbonate levels will be determined

  9. Bicarbonate concentration of timed pancreatic juice

    Time frame: 15 minutes

    Concentration of bicarbonate levels will be determined

  10. Bicarbonate concentration of timed pancreatic juice

    Time frame: 20 minutes

    Concentration of bicarbonate levels will be determined

  11. Bicarbonate concentration of timed pancreatic juice

    Time frame: 25 minutes

    Concentration of bicarbonate levels will be determined

  12. Bicarbonate concentration of timed pancreatic juice

    Time frame: 30 minutes

    Concentration of bicarbonate levels will be determined

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: IDST

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2017
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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