Biliary Stricture, Cholangiocarcinoma
Conditions
Keywords
intraductal ultrasound, digital single-operator cholangioscopy, indeterminate biliary stricture
Brief 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.
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.
Interventions
None listed
Sponsors
Soonchunhyang University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 19 to under 80 2. Presence of nonicteric biliary stricture 3. Previous endoscopic sphincterotomy or papillary balloon dilatation
Exclusion criteria
1. Bleeding tendency (INR > 1.5 or platelets < 50000 mm3) 2. Contraindication to ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy of SOC | From enrollment through study completion, an average of 1 year | sensitivity, specificity, and accuracy of SOC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of IDUS | From enrollment through study completion, an average of 1 year | sensitivity, specificity, and accuracy of IDUS |
| Technical success of SOC | From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed | Successful observation of extrahepatic duct using SOC |
| Technical success of IDUS | From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed | Successful observation of extrahepatic duct using IDUS |
| Adverse event | From enrollment through study completion, an average of 1 year | All adverse event according to the American Society of Gastrointestinal Endoscopy criteria |
Contacts
Primary ContactJong Ho Moon, Dr.
Backup ContactIl Sang Shin, Dr.
Outcome results
None listed