Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

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).

Study Overview

• Status: Completed
• Conditions: Primary Sclerosing Cholangitis (PSC)
• Intervention / Treatment: Device: SpyGlass DS I - II

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3H 0V5
      • Aspen Woods Clinic
• Netherlands
  • Amsterdam-Zuidoost, Netherlands, 1105 AZ
    • Academic Medical Center
• Norway
  • Oslo, Norway, 0372
    • Rikshospitalet University Hospital
• United States
  • California
    • Davis, California, United States, 95616
      • Sutter Davis Hospital
    • Sacramento, California, United States, 95817
      • UC Davis Health
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PSC

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Johannes Eksteen, MD, PhD, Aspen Woods Clinic; Principal Investigator: Douglas Adler, MD, University of Utah Hospital and Clinic; Principal Investigator: Lars Aabakken, MD, PhD, Rikshospitalet Oslo University Hospital; Principal Investigator: Cyriel Ponsioen, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Sooraj Tejaswi, MD, PhD, Sutter Davis Hospital; Principal Investigator: Christopher Bowlus, MD, PhD, UC Davis Health

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cholangiocarcinoma; ERCP; PSC; primary sclerosing cholangitis; per oral cholangioscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis; Cholangitis, Sclerosing
• Other Study ID Numbers: E7136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No