Skip to main content
OpenTrials
Completed

NCT Number: NCT03766035

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Sclerosing Cholangitis (PSC) Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholangitis Cholangitis, Sclerosing Digestive System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aspen Woods Clinic, Calgary, Alberta, Canada

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2018
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.