Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

NCT03766035 | Completed FDA Device

• 1 other identifier: E7136
• Study Type: observational
• Target: 43
• Locations: 4 countries
• Sites: 6

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).

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Technical Success - Ability to advance the scope.

  Baseline

• Rate of Adverse Events

  From index through study completion, an average of one year

• Proportion of patients identified for repeat procedure.

  During index procedure

• Correspondence of Biopsies

  From index through study completion, an average of one year

Study Arms (1)

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

Interventions

SpyGlass DS I - II 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.

Consented, enrolled PSC patients undergoing ERCP + SpyGlass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PSC

You may qualify if:

• Confirmed diagnosis of PSC
• 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
• Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP
• Written informed consent from patient to participate in the study, including compliance with study procedures.

You may not qualify if:

• Contraindication for an ERCP or POCS
• History of liver transplantation
• Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging
• History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment
• INR \> 1.5 or platelets count \< 50,000
• Age \< 18 years
• Pregnant women or women trying to become pregnant

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (6)

Sutter Davis Hospital

Davis, California, 95616, United States

Location

UC Davis Health

Sacramento, California, 95817, United States

Location

University of Utah Hospital and Clinic

Salt Lake City, Utah, 84132, United States

Location

Aspen Woods Clinic

Calgary, Alberta, T3H 0V5, Canada

Location

Academic Medical Center

Amsterdam-Zuidoost, 1105 AZ, Netherlands

Location

Rikshospitalet University Hospital

Oslo, 0372, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum collection

MeSH Terms

Conditions

Cholangitis, Sclerosing; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: December 5, 2018
• Study Start: December 6, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

CA (1); NL (1); US (3); NO (1)