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Trial record 6 of 92 for:    Primary Sclerosing Cholangitis

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

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ClinicalTrials.gov Identifier: NCT03766035
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
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).

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).

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Study Type : Observational
Estimated Enrollment : 105 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 : June 2021
Estimated Study Completion Date : August 2021


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.




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


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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 baseline imaging performed within 3 months 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766035


Contacts
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Contact: Danielle Vannan, PhD 508-683-4139 Danielle.Vannan@bsci.com
Contact: Srey Yin 508-683-4162 Srey.Yin@bsci.com

Locations
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United States, Utah
University of Utah Hospital and Clinic Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Linda Jo Taylor       lindajo.taylor@hsc.utah.edu   
Principal Investigator: Douglas Adler, MD         
Canada, Alberta
Aspen Woods Clinic Recruiting
Calgary, Alberta, Canada, T3H 0V5
Contact: Joni Tsougrianis       research@aspenwoodsclinic.com   
Principal Investigator: Johannes Eksteen, MD, PhD         
Sub-Investigator: Rachid Mohamed, MD         
Sub-Investigator: Nauzer Forbes, MD         
Netherlands
Academic Medical Center Not yet recruiting
Amsterdam-Zuidoost, Netherlands, 1105 AZ
Principal Investigator: Cyriel Ponsioen, MD, PhD         
Sub-Investigator: Jeanin van Hooft, MD         
Norway
Rikshospitalet University Hospital Not yet recruiting
Oslo, Norway, 0372
Contact: Siv Furholm       siv.furholm@ous-hf.no   
Principal Investigator: Lars Aabakken, MD, PhD         
Sub-Investigator: Vemund Paulsen, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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
Principal Investigator: Cyriel Ponsioen, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03766035     History of Changes
Other Study ID Numbers: E7136
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases