Clinical trial · Observational
Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
The Usefulness of Disposable Digital Single-operator Cholangioscopy and Intraductal Ultrasound in the Assessment of Nonicteric Biliary Strictures: A Prospective Observational Study
NCT06369896CI-TRIAL-00076137Spy+IDUSnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Nonicteric stricture cohort
- description
- Patients with nonicteric biliary stricture
Primary outcomes (1)
- measure
- diagnostic accuracy of SOC
- timeFrame
- From enrollment through study completion, an average of 1 year
- description
- sensitivity, specificity, and accuracy of SOC
Secondary outcomes (4)
- measure
- Diagnostic accuracy of IDUS
- timeFrame
- From enrollment through study completion, an average of 1 year
- description
- sensitivity, specificity, and accuracy of IDUS
- measure
- Technical success of SOC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.