MedTrace Logo

Diagnosis of Bile Duct Strictures

NCT02000999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2019-05-13

No results posted yet for this study

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

Interventions

OTHER

brushing of bile duct strictures for cytology

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-01-02
Completion
2019-01-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000999 on ClinicalTrials.gov