Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Study Overview
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Brief Summary
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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).

Detailed Description
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The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

Official Title
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Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Conditions
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Primary Sclerosing Cholangitis (PSC)

Intervention / Treatment
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* Device: SpyGlass DS I - II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of PSC 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 Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP Written informed consent from patient to participate in the study, including compliance with study procedures. Exclusion Criteria: Contraindication for an ERCP or POCS History of liver transplantation Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment INR > 1.5 or platelets count < 50,000 Age < 18 years Pregnant women or women trying to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consented, enrolled PSC patients undergoing ERCP + SpyGlass<br>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. | Device: SpyGlass DS I - II<br>* The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma | Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation. | 12 months | 
| POCS-guided Biopsy for Early Detection of Cholangiocarcinoma | Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success - Ability to advance the scope. | Ability to advance the cholangioscope to the target stricture, ability to visualize the stricture and ability to obtain a tissue sample with Spy Bite where applicable. | Baseline | 
| Rate of Adverse Events | Serious adverse events from initial POCS procedure until end of follow-up. | From index through study completion, an average of one year | 
| Proportion of patients identified for repeat procedure. | Proportion of patients identified for repeat procedure considering the addition of Spy Glass DS visualization and Spy Bite biopsy at Index compared to the proportion identified for repeat procedure without consideration of Spy Glass DS visualization and Spy Bite biopsy at Index. | During index procedure | 
| Correspondence of Biopsies | Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis. | From index through study completion, an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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per oral cholangioscopy, PSC, cholangiocarcinoma, primary sclerosing cholangitis, ERCP