Cholangiopancreatography, Endoscopic RetrogradeIDSTNCT03263481
Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?
A study testing Intraductal secretin test (IDST) in people with Cholangiopancreatography, Endoscopic Retrograde, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- Intraductal secretin test (IDST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Intraductal secretin test (IDST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraductal secretin test (IDST)Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraductal secretin test (IDST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 5 minutes
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 10 minutes
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 15 minutes
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 20 minutes
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 25 minutes
Secretory flow rates measured by volume
Volume of pancreatic juices will be collected
Measured: 30 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 5 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 10 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 15 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 20 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 25 minutes
Bicarbonate concentration of timed pancreatic juice
Concentration of bicarbonate levels will be determined
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Fogel, Indiana University
- Investigators
- Evan L Fogel, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263481
- Sponsor's protocol ID
- 1203008365
- Acronym
- IDST
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?
- ClinicalTrials.gov ID
- NCT03263481
- Acronym / sponsor ID
- IDST / 1203008365
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP with inadvertent pancreatic cannulation | Experimental | Procedure: Intraductal secretin test (IDST)Subjects undergoing ERCP for a biliary indication in which inadvertent pancreatic cannulation occurs will undergo intraductal secretin testing per the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | ERCP with inadvertent pancreatic cannulation |
Primary outcome
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
Bicarbonate concentration of timed pancreatic juice
Time frame: 15 minutes
Concentration of bicarbonate levels will be determined
Bicarbonate concentration of timed pancreatic juice
Time frame: 20 minutes
Concentration of bicarbonate levels will be determined
Bicarbonate concentration of timed pancreatic juice
Time frame: 25 minutes
Concentration of bicarbonate levels will be determined
Bicarbonate concentration of timed pancreatic juice
Time frame: 30 minutes
Concentration of bicarbonate levels will be determined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan L Fogel, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraductal secretin test (IDST) in people with Cholangiopancreatography, Endoscopic Retrograde, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secretory flow rates measured by volume (time frame: 5 minutes). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.