Clinical trial · Interventional
Confocal Endomicroscopy for Biliary Strictures -Phase I
A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I
NCT00892632CI-TRIAL-00006332terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficult (slow) Enrollment
Summary
Brief summary (as posted)
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP and Confocal imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 1\. To compare confocal image characteristics of benign vs. malignant biliary strictures
- interventionNames
- Procedure: ERCP and Confocal imaging
Primary outcomes (1)
- measure
- Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Secondary Aim: 1. To compare the technical feasibility (percentage of images rated as adequate or better) and the quality of the images obtained via fluoroscopy-guided pCLE versus cholangioscopy-guided pCLE.
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP. * Evidence of biliary obstruction as defined by elevated direct bilirubin (\> 1.5ULN) and dilation of the common or hepatic ducts \> 8mm) on imaging studies. Exclusion Criteria: * Unwilling/unable to consent. * Definite pancreatic mass on CT/MR. * Allergy to Fluorescein. * Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care) * Indwelling metal biliary stent.
References
Publications (0)
Data not yet available
No reference posted for this study.