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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COMPLETED
110 participants
OBSERVATIONAL
2013-11-30
2019-01-02
Brief Summary
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The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures.
Primary aim:
To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy.
Secondary aims:
1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with bile duct strictures
brushing of bile duct strictures for cytology
Interventions
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brushing of bile duct strictures for cytology
Eligibility Criteria
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Inclusion Criteria
2. Presence of a biliary stricture
3. Ability to provide written informed consent.
Exclusion Criteria
2. Inability to cannulate the common bile duct
3. Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)
18 Years
99 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Locations
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Washington University
St Louis, Missouri, United States
Countries
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Other Identifiers
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Cytology 2013-201211068
Identifier Type: -
Identifier Source: org_study_id
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