Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-80
SponsorSoonchunhyang University Hospital
About this trial
This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 19 to under 80
Presence of nonicteric biliary stricture
Previous endoscopic sphincterotomy or papillary balloon dilatation
Disqualifiers
Bleeding tendency (INR > 1.5 or platelets < 50000 mm3)
Contraindication to ERCP
Trial population
Patients with indeterminate nonicteric (Bilirubin \< 2mg/dL) biliary stricture
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
36 Participants
are grouped into 1 trial groupGroup A: Nonicteric stricture cohort
Trial outcomes
Primary outcomes
1
diagnostic accuracy of SOC
sensitivity, specificity, and accuracy of SOC
Time frame
From enrollment through study completion, an average of 1 yearSecondary outcomes
1
Diagnostic accuracy of IDUS
sensitivity, specificity, and accuracy of IDUS
Time frame
From enrollment through study completion, an average of 1 year2
Technical success of SOC
Successful observation of extrahepatic duct using SOC
Time frame
From the time the cholangioscope is inserted into the working channel of the endoscope until it is removed3
Technical success of IDUS
Successful observation of extrahepatic duct using IDUS
Time frame
From the time the intraductal probe is inserted into the working channel of the endoscope until it is removed4
Adverse event
All adverse event according to the American Society of Gastrointestinal Endoscopy criteria
Time frame
From enrollment through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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