Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
NCT ID: NCT03211169
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2017-07-29
2019-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Pediatric Biopsy Forceps directed biopsies
Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
Biopsies of bile duct stricture with pediatric biopsy forceps
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Cholangioscopy-directed biopsies
Biopsies of the stricture will be taken under cholangioscopic guidance after bile duct brushings have been obtained.
Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
Interventions
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Biopsies of bile duct stricture with pediatric biopsy forceps
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Biopsies of bile duct stricture with cholangioscopy-directed biopsies
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
Eligibility Criteria
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Inclusion Criteria
2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
4. Expected patient survival of at least 90 days
5. High likelihood of patient follow-up
6. Patient is able to give a written informed consent
7. Patient is willing and able to comply with the study procedures
Exclusion Criteria
2. Children \< 18 years of age
3. Pregnant women
4. Patients with impaired decision-making
5. Healthy volunteers
6. Primary Sclerosing Cholangitis (PSC)
7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
8. Patients with any contraindication to endoscopic procedure
9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
10. Patients unable to provide informed consent
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
The University of Texas Health Science Center, Houston
OTHER
Stanford University
OTHER
Responsible Party
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Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Locations
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Stanford University Medical Center
Stanford, California, United States
Countries
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Other Identifiers
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40988
Identifier Type: -
Identifier Source: org_study_id
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