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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonicteric stricture cohort | Patients with nonicteric biliary stricture |
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| Measure | Description | Time Frame |
|---|---|---|
| diagnostic accuracy of SOC | sensitivity, specificity, and accuracy of SOC | From enrollment through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of IDUS | sensitivity, specificity, and accuracy of IDUS | From enrollment through study completion, an average of 1 year |
| Technical success of SOC | Successful observation of extrahepatic duct using SOC |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indeterminate nonicteric (Bilirubin < 2mg/dL) biliary stricture
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Ho Moon, Dr. | Contact | 800-324-2246 | jhmoonsch@gmail.com | |
| Il Sang Shin, Dr. | Contact | 800-324-2246 | 110554@schmc.ac.kr |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 | 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 | From enrollment through study completion, an average of 1 year |
| D009369 | Neoplasms |