Clinical trial NCT03766035: Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
Official title: Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sclerosing Cholangitis (PSC)
Keywords: per oral cholangioscopy
PSC
cholangiocarcinoma
primary sclerosing cholangitis
ERCP
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with PSC

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).

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).

Eligibility 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

Primary outcomes:
measure: Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma
timeFrame: 12 months
measure: POCS-guided Biopsy for Early Detection of Cholangiocarcinoma
timeFrame: 12 months
Secondary outcomes:
measure: Technical Success - Ability to advance the scope.
timeFrame: Baseline
measure: Rate of Adverse Events
timeFrame: From index through study completion, an average of one year
measure: Proportion of patients identified for repeat procedure.
timeFrame: During index procedure
measure: Correspondence of Biopsies
timeFrame: From index through study completion, an average of one year
Other outcomes:
Locations:
city: Davis
country: United States
facility: Sutter Davis Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinic
state: Utah
city: Calgary
country: Canada
facility: Aspen Woods Clinic
state: Alberta
city: Amsterdam-Zuidoost
country: Netherlands
facility: Academic Medical Center
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital
Study officials:
affiliation: Aspen Woods Clinic
name: Johannes Eksteen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah Hospital and Clinic
name: Douglas Adler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rikshospitalet Oslo University Hospital
name: Lars Aabakken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Cyriel Ponsioen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Davis Hospital
name: Sooraj Tejaswi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis Health
name: Christopher Bowlus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: