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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
Stanford University Medical Center
Stanford, California, United States
Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
Malignancy or no malignancy diagnosis obtained from stricture biopsy
Time frame: 1 week
Cost
Cumulative $ from devices used and facility fees with each approach
Time frame: 2 years
Radiation Exposure
Total Dose, Fluoroscopy Time, Dose Area Product, Effective dose per fluoroscopy machine readings
Time frame: 2 years
Procedure Duration
in minutes
Time frame: 2 years
Latency to diagnosis
Duration in days from initial procedure to diagnosis of benign or malignant stricture
Time frame: 2 years
Adverse Events
(Pancreatitis, Bleeding, Infection, Perforation, Death to be assessed one day, one week post-procedure
Time frame: 2 weeks
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