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
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