Clinical trial · Observational
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
NCT03766035CI-TRIAL-00063401completedClinicalTrials.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)
To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).
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 |
|---|---|---|---|
| Primary Sclerosing Cholangitis (PSC) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SpyGlass DS I - II | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Consented, enrolled PSC patients undergoing ERCP + SpyGlass
- description
- Patients with PSC who have been consented and enrolled in the study will undergo ERCP with the addition of SpyGlass as indicated by their treating physician.
- interventionNames
- Device: SpyGlass DS I - II
Primary outcomes (2)
- measure
- Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma
- timeFrame
- 12 months
- description
- Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.
- measure
- POCS-guided Biopsy for Early Detection of Cholangiocarcinoma
- timeFrame
- 12 months
- description
- Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of PSC 2. Clinical indication for ERCP per local standard of practice, such as suspicion of potential malignancy based on worsening cholestatic values or clinical presentation (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology 3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP 4. Written informed consent from patient to participate in the study, including compliance with study procedures. Exclusion Criteria: 1. Contraindication for an ERCP or POCS 2. History of liver transplantation 3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging 4. History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment 5. INR \> 1.5 or platelets count \< 50,000 6. Age \< 18 years 7. Pregnant women or women trying to become pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.