Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Completed

• Conditions: Primary Sclerosing Cholangitis (PSC)
• Interventions: Device: SpyGlass DS I - II

• Registration Number: NCT03766035
• Lead Sponsor: Boston Scientific Corporation

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).

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2018-12-06
• Primary Completion: 2022-12-12
• Study Completion: 2022-12-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consented, enrolled PSC patients undergoing ERCP + SpyGlass	SpyGlass DS I - II	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (6)

University of Utah Hospital and Clinic; 🇺🇸 Salt Lake City, Utah, United States

Sutter Davis Hospital; 🇺🇸 Davis, California, United States

UC Davis Health; 🇺🇸 Sacramento, California, United States

Aspen Woods Clinic; 🇨🇦 Calgary, Alberta, Canada

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Academic Medical Center; 🇳🇱 Amsterdam-Zuidoost, Netherlands