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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02000999

Enrollment

110

Registered

2013-12-04

Start date

2013-11-30

Completion date

2019-01-02

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Stricture, Cholangiocarcinoma, Chronic Pancreatitis, Pancreatic Cancer

Keywords

Bile duct stricture, Cholangiocarcinoma, Pancreatic cancer, Chronic pancreatitis

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: 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

OTHERbrushing of bile duct strictures for cytology

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

1. Patients age: \> 18 years 2. Presence of a biliary stricture 3. Ability to provide written informed consent.

Exclusion criteria

1. Severe coagulopathy (INR \> 1.8) or thrombocytopenia (platelet count \<50,000) 2. Inability to cannulate the common bile duct 3. Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)

Design outcomes

Primary

Measure	Time frame
• 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

Secondary

Measure	Time frame
• Complications (pancreatitis, bleeding, perforation, cholangitis)	2 years
• Technical success and ease of procedure	2 years
• Specimen adequacy	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026