Diagnosis of Bile Duct Strictures
The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is increased procedure duration).
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.
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.
- To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
- To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.
Bile Duct Stricture
Other: brushing of bile duct strictures for cytology
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||The Diagnostic Yield of Malignancy Comparing Cytology, FISH and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study|
- • Sensitivity accuracy of cytology, FISH and mutation profiling using histologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- • Specimen adequacy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- • Complications (pancreatitis, bleeding, perforation, cholangitis) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- • Technical success and ease of procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|Patients with bile duct strictures||Other: brushing of bile duct strictures for cytology|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000999
|United States, Missouri|
|St Louis, Missouri, United States, 63110|
|Contact: Vladimir M Kushnir, MD 314-454-5960|
|Principal Investigator: Vladimir M Kushnir, MD|