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NCT02000999 · ClinicalTrials.gov registry record
Diagnosis of Bile Duct Strictures
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 110
- Enrollment target
NCT02000999: Completed study, sponsored by Washington University School of Medicine.
NCT02000999 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02000999 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 110 participants
- Enrollment target
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.
Interventions
- OTHER brushing of bile duct strictures for cytology
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2013-11 |
| Est. Completion | 2019-01-02 |
What the finished NCT02000999 record still lists
NCT02000999 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which brushing of bile duct strictures for cytology is the first listed.
NCT02000999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02000999 about?
NCT02000999 is a clinical study titled "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 ...
What is the current status of trial NCT02000999?
This trial is currently completed. The enrollment target is 110 participants. The study started on 2013-11. Estimated completion is 2019-01-02.
What interventions are being tested in trial NCT02000999?
The interventions under investigation include: brushing of bile duct strictures for cytology (OTHER).
Who is sponsoring clinical trial NCT02000999?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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