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).
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).
Study Type
OBSERVATIONAL
Enrollment
43
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.
Sutter Davis Hospital
Davis, California, United States
UC Davis Health
Sacramento, California, United States
University of Utah Hospital and Clinic
Salt Lake City, Utah, United States
Aspen Woods Clinic
Calgary, Alberta, Canada
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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: Baseline
Rate of Adverse Events
Serious adverse events from initial POCS procedure until end of follow-up.
Time frame: 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.
Time frame: During index procedure
Correspondence of Biopsies
Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.
Time frame: From index through study completion, an average of one year
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Academic Medical Center
Amsterdam-Zuidoost, Netherlands
Rikshospitalet University Hospital
Oslo, Norway