Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

• ClinicalTrials.gov Identifier: NCT03766035
• Recruitment Status: Active, not recruiting
• First Posted: December 5, 2018
• Last Update Posted: March 10, 2022
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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).

Condition or disease	Intervention/treatment
Primary Sclerosing Cholangitis (PSC)	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 Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
• Actual Study Start Date: December 6, 2018
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma [ Time Frame: 12 months ]
   Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.
2. POCS-guided Biopsy for Early Detection of Cholangiocarcinoma [ Time Frame: 12 months ]
   Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.

Secondary Outcome Measures :

1. Technical Success - Ability to advance the scope. [ Time Frame: 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.
2. Rate of Adverse Events [ Time Frame: From index through study completion, an average of one year ]
   Serious adverse events from initial POCS procedure until end of follow-up.
3. Proportion of patients identified for repeat procedure. [ Time Frame: 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.
4. Correspondence of Biopsies [ Time Frame: 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.

Biospecimen Retention:   Samples Without DNA

Serum collection

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PSC

Criteria

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

Contacts and Locations

Locations

United States, California

Sutter Davis Hospital

Davis, California, United States, 95616

UC Davis Health

Sacramento, California, United States, 95817

United States, Utah

University of Utah Hospital and Clinic

Salt Lake City, Utah, United States, 84132

Canada, Alberta

Aspen Woods Clinic

Calgary, Alberta, Canada, T3H 0V5

Netherlands

Academic Medical Center

Amsterdam-Zuidoost, Netherlands, 1105 AZ

Norway

Rikshospitalet University Hospital

Oslo, Norway, 0372

Sponsors and Collaborators

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

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03766035
• Other Study ID Numbers: E7136
• First Posted: December 5, 2018
• Last Update Posted: March 10, 2022
• Last Verified: March 2022

• 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

Keywords provided by Boston Scientific Corporation:

per oral cholangioscopy; PSC; cholangiocarcinoma; primary sclerosing cholangitis; ERCP

Additional relevant MeSH terms:

Cholangitis; Cholangitis, Sclerosing; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases