CholangiocarcinomaSpy+IDUSNCT06369896
Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
An observational study of Cholangiocarcinoma and Biliary Stricture, run by Soonchunhyang University Hospital.
Trial summary
This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cholangiocarcinoma, Biliary Stricture
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2024to 25 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indeterminate nonicteric (Bilirubin \< 2mg/dL) biliary stricture
Who may be able to join
- Patients aged 19 to under 80
- Presence of nonicteric biliary stricture
- Previous endoscopic sphincterotomy or papillary balloon dilatation
Who cannot join
- Bleeding tendency (INR \> 1.5 or platelets \< 50000 mm3)
- Contraindication to ERCP
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study
This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.
Read the detailed description
Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Keywords
- intraductal ultrasound, digital single-operator cholangioscopy, indeterminate biliary stricture
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nonicteric stricture cohort | Patients with nonicteric biliary stricture |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of SOC
sensitivity, specificity, and accuracy of SOC
Measured: From enrollment through study completion, an average of 1 year
Secondary outcomes (4)
Diagnostic accuracy of IDUS
sensitivity, specificity, and accuracy of IDUS
Measured: From enrollment through study completion, an average of 1 year
Technical success of SOC
Successful observation of extrahepatic duct using SOC
Measured: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
Technical success of IDUS
Successful observation of extrahepatic duct using IDUS
Measured: From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
Adverse event
All adverse event according to the American Society of Gastrointestinal Endoscopy criteria
Measured: From enrollment through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start5 May 2024 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Moon, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369896
- Sponsor's protocol ID
- SpyIDUSForNonictericStricture
- Acronym
- Spy+IDUS
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06369896
- Acronym / sponsor ID
- Spy+IDUS / SpyIDUSForNonictericStricture
- Conditions
- Cholangiocarcinoma, Biliary Stricture
- Keywords
- intraductal ultrasound, digital single-operator cholangioscopy, indeterminate biliary stricture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 5 May 2024 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 17 Apr 2024 (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.
This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.
Detailed description
Although early and accurate diagnosis of cholangiocarcinoma from the biliary stricture is important, accurate differential diagnosis is still difficult even in computed tomography and magnetic resonance imaging. We planned to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of biliary stricture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonicteric stricture cohort | – | –Patients with nonicteric biliary stricture |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indeterminate nonicteric (Bilirubin \< 2mg/dL) biliary stricture
Key inclusion criteria (3 listed)
- Patients aged 19 to under 80
- Presence of nonicteric biliary stricture
- Previous endoscopic sphincterotomy or papillary balloon dilatation
Key exclusion criteria (2 listed)
- Bleeding tendency (INR \> 1.5 or platelets \< 50000 mm3)
- Contraindication to ERCP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic accuracy of SOC
Time frame: From enrollment through study completion, an average of 1 year
sensitivity, specificity, and accuracy of SOC
4 secondary outcomes
Diagnostic accuracy of IDUS
Time frame: From enrollment through study completion, an average of 1 year
Technical success of SOC
Time frame: From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed
Technical success of IDUS
Time frame: From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed
Adverse event
Time frame: From enrollment through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma and Biliary Stricture, run by Soonchunhyang University Hospital.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong Ho Moon, Dr. (800-324-2246, jhmoonsch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy of SOC (time frame: From enrollment through study completion, an average of 1 year). 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 17 Apr 2024.