Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-06

Study Completion Date

2022-12-12

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).

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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).

Conditions

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Primary Sclerosing Cholangitis (PSC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Consented, enrolled PSC patients undergoing ERCP + SpyGlass

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.

SpyGlass DS I - II

Intervention Type DEVICE

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.

Interventions

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SpyGlass 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No