An observational study in Cholangiocarcinoma and Biliary Stricture, sponsored by Soonchunhyang University Hospital. Not yet recruiting. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Soonchunhyang University Hospital · Observational
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.
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.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 36 is below the median of 196 across 161 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Soonchunhyang University Hospital is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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Patients with indeterminate nonicteric (Bilirubin \< 2mg/dL) biliary stricture
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with nonicteric biliary stricture
diagnostic accuracy of SOC
sensitivity, specificity, and accuracy of SOC
Time frame: From enrollment through study completion, an average of 1 year
Diagnostic accuracy of IDUS
sensitivity, specificity, and accuracy of IDUS
Time frame: From enrollment through study completion, an average of 1 year
Technical success of SOC
Successful observation of extrahepatic duct using 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
Successful observation of extrahepatic duct using IDUS
Time frame: 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
Time frame: From enrollment through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Dec 2025, 19 months later.
Of 70 observational studies under Cholangiocarcinoma, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 33. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Soonchunhyang University Hospital