Brief Title
Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Official Title
Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
Brief Summary
Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of
bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies
for obtaining diagnostic tissue from biliary strictures.
Study Type
Interventional
Primary Outcome
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Secondary Outcome
Cost
Condition
Cholangiocarcinoma
Intervention
Biopsies of bile duct stricture with pediatric biopsy forceps
Study Arms / Comparison Groups
Pediatric Biopsy Forceps directed biopsies
Description: Biopsies of the stricture will be taken with Pediatric Biopsy Forceps after bile duct brushings have been obtained.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12
Start Date
July 29, 2017
Completion Date
September 1, 2019
Primary Completion Date
September 1, 2019
Eligibility Criteria
Inclusion Criteria:
1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary
stricture, without obvious pancreatic mass
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:
1. Patients with imaging suggestive of pancreatic tumor
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03211169
Organization ID
40988
Responsible Party
Principal Investigator
Study Sponsor
Stanford University
Collaborators
University of Rochester
Study Sponsor
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Verification Date
November 2019