Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) Clinical Trial

Official title:

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766035
• Other study ID #: E7136
• Status: Completed
• Start date: December 6, 2018
• Est. completion date: December 12, 2022

Study information

• Verified date: January 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis (PSC)

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Aspen Woods Clinic	Calgary	Alberta
Netherlands	Academic Medical Center	Amsterdam-Zuidoost
Norway	Rikshospitalet University Hospital	Oslo
United States	Sutter Davis Hospital	Davis	California
United States	UC Davis Health	Sacramento	California
United States	University of Utah Hospital and Clinic	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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