Diagnosis of Bile Duct Strictures

Completed

Conditions studied: Bile Duct Stricture, Cholangiocarcinoma, Pancreatic Cancer, Chronic Pancreatitis

In brief

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.

Key facts

Study ID

NCT02000999

Run by

Washington University School of Medicine

People needed

110

Starts

2013-11-01

Expected to finish

2019-01-02

Last updated by the study team

2019-05-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age: > 18 years
• Presence of a biliary stricture
• Ability to provide written informed consent.

You may not qualify if…

• Severe coagulopathy (INR > 1.8) or thrombocytopenia (platelet count <50,000)
• Inability to cannulate the common bile duct
• Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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