Comparison of On-Site Verus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
The diagnostic accuracy rate of cholangioscopy-guided biopsy is only 50%. This translates to
the need for performing repeat procedures to establish a diagnosis and therefore delays
patient treatment. The biopsy specimen obtained at cholangioscopy are usually processed in
an offsite pathology lab. We believe that if a pathologist can assess the tissue sample
during the procedure itself (onsite) and provide feedback, the diagnostic accuracy rate will
improve. This translates to better (faster) diagnosis and early treatment. Therefore, we
will be comparing onsite versus offsite evaluation of bile duct biopsy specimens to
determine which method yields a better diagnosis.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
confirmation of cancer
The primary endpoint of the study is to compare the diagnostic accuracy, or confirmation of cancer rates between two different methods used for processing specimens obtained from the bile duct.
up to12 months
Shyam Varadarajulu, MD
United States: Institutional Review Board
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