Diagnosis of Bile Duct Strictures

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02000999

Collaborator

(none)

110

Enrollment

Location

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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.

Condition or Disease	Intervention/Treatment	Phase
Bile Duct Stricture Cholangiocarcinoma Pancreatic Cancer Chronic Pancreatitis	Other: brushing of bile duct strictures for cytology

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jan 2, 2019

Actual Study Completion Date :

Jan 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with bile duct strictures	Other: brushing of bile duct strictures for cytology

Arm

Intervention/Treatment

Patients with bile duct strictures

Other: brushing of bile duct strictures for cytology

Outcome Measures

Primary Outcome Measures

• Sensitivity accuracy of cytology, FISH and mutation profiling using histologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard. [2 years]