Primary Sclerosing Cholangitis (PSC)NCT03766035
Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
An observational study of Primary Sclerosing Cholangitis (PSC), run by Boston Scientific Corporation at 6 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- SpyGlass DS I - II
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 6 Dec 2018to 12 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with PSC
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Sutter Davis Hospital
Davis, California, 95616
UC Davis Health
Sacramento, California, 95817
University of Utah Hospital and Clinic
Salt Lake City, Utah, 84132
About this study
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).
Read the 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).
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- SpyGlass DS I - II
- Keywords
- per oral cholangioscopy, PSC, cholangiocarcinoma, primary sclerosing cholangitis, ERCP
- Medical subject headings
- Cholangitis, Sclerosing, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlass DS I - IIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SpyGlass DS I - II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: Baseline
Rate of Adverse Events
Serious adverse events from initial POCS procedure until end of follow-up.
Measured: 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.
Measured: During index procedure
Correspondence of Biopsies
Correlation between histopathology of Spy Bite biopsies collected during the initial POCS procedure and final diagnosis.
Measured: From index through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start6 Dec 2018
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Eksteen, MD, PhD, Principal investigator, Aspen Woods ClinicDouglas Adler, MD, Principal investigator, University of Utah Hospital and ClinicLars Aabakken, MD, PhD, Principal investigator, Rikshospitalet Oslo University HospitalCyriel Ponsioen, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Sooraj Tejaswi, MD, PhD, Principal investigator, Sutter Davis HospitalChristopher Bowlus, MD, PhD, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766035
- Sponsor's protocol ID
- E7136
- Status last verified
- Jan 2023
- First submitted
- 8 Nov 2018
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT03766035
- Acronym / sponsor ID
- E7136
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Keywords
- per oral cholangioscopy, PSC, cholangiocarcinoma, primary sclerosing cholangitis, ERCP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consented, enrolled PSC patients undergoing ERCP + SpyGlass | – | Device: SpyGlass DS I - IIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with PSC
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpyGlass DS I - IIThe 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. | Device | Consented, enrolled PSC patients undergoing ERCP + SpyGlass |
Primary outcome
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.
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.
4 secondary outcomes
Technical Success - Ability to advance the scope.
Time frame: Baseline
Rate of Adverse Events
Time frame: From index through study completion, an average of one year
Proportion of patients identified for repeat procedure.
Time frame: During index procedure
Correspondence of Biopsies
Time frame: From index through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Eksteen, MD, PhD principal investigator
Aspen Woods Clinic
Douglas Adler, MD principal investigator
University of Utah Hospital and Clinic
Lars Aabakken, MD, PhD principal investigator
Rikshospitalet Oslo University Hospital
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sclerosing Cholangitis (PSC), run by Boston Scientific Corporation at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Netherlands, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.