Primary Sclerosing Cholangitis (PSC)
Conditions
Keywords
per oral cholangioscopy, PSC, cholangiocarcinoma, primary sclerosing cholangitis, ERCP
Brief summary
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
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).
Interventions
DEVICESpyGlass DS I - II
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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma | 12 months | Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation. |
| POCS-guided Biopsy for Early Detection of Cholangiocarcinoma | 12 months | Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success - Ability to advance the scope. | Baseline | 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. |
| Rate of Adverse Events | From index through study completion, an average of one year | Serious adverse events from initial POCS procedure until end of follow-up. |
| Proportion of patients identified for repeat procedure. | During index 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. |
| Correspondence of Biopsies | From index through study completion, an average of one year | Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis. |
Countries
Canada, Netherlands, Norway, United States
Outcome results
None listed