NCT02000999

Diagnosis of Bile Duct Strictures

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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. 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.

Conditions

• Bile Duct Stricture
• Cholangiocarcinoma
• Pancreatic Cancer
• Chronic Pancreatitis

Interventions

Type	Name	Description
OTHER	brushing of bile duct strictures for cytology

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-01-02
• Completion: 2019-01-02
• First posted: 2013-12-04
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States