Indeterminate Bile Duct Stricture Clinical Trial
Official title:
Optimizing the Role of ERCP in Evaluating Indeterminate Bile Duct Strictures
Differentiating malignant from benign bile duct strictures is a conundrum, since no
diagnostic test is highly sensitive for diagnosing cancer. While ERCP is effective in
palliating obstructive jaundice, standard diagnostic tools in ERCP have a low diagnostic
sensitivity and confirm the stricture's etiology in <50% of cases. During the first ERCP,
standard practice is to obtain routine cytology (RC) using a single brush sample. If this is
not diagnostic, patients often undergo repeat ERCP, endoscopic ultrasound or other,
increasing health care costs. The incremental yield of performing alternate ERCP-based
diagnostic tools during the first ERCP including fluorescence in situ hybridization (FISH),
cholangioscopy w/biopsy and multiple brushes for routine cytology is currently unknown.
There are no studies quantifying the amount of testing utilized to firmly diagnose the
etiology of the stricture, or the most efficient combination of diagnostic tools during the
first ERCP. These are important knowledge deficiencies since a definitive tissue diagnosis
during the first ERCP could reduce the need for downstream tests and expedite treatment,
thereby improving patient-centered and economic outcomes. The added costs of using multiple
tools during the first ERCP may be offset by these benefits.
Among patients with indeterminate bile duct strictures, the investigators hypothesize that a
multimodality approach will be more sensitive without a significant reduction in specificity
compared to multiple brush samples for routine cytology. The investigators will test this
hypothesis using an experimental trial design by randomizing patients during their first
ERCP to multiple brushing samples for cytology vs. a single brush sample for cytology + FISH
+ cholangioscopy w/biopsy. To obtain preliminary data for a definitive multi-center trial,
the investigators propose a pilot and feasibility study to compare the performance
characteristics of each approach by evaluating the prospective clinical course, including
treatment delay, quality of life, and life expectancy for each enrolled patient. If our
hypothesis is validated in a subsequent definitive study, the standard approach to tissue
sampling during the first ERCP may be altered.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic