Diagnosis of Bile Duct Strictures

Completed

• Conditions: Pancreatic Cancer; Chronic Pancreatitis; Bile Duct Stricture; Cholangiocarcinoma
• Interventions: Other: brushing of bile duct strictures for cytology

• Registration Number: NCT02000999
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2019-01-02
• Study Completion: 2019-01-02
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with bile duct strictures	brushing of bile duct strictures for cytology	-

Primary Outcome Measures

Name	Time	Method
• 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 Outcome Measures

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

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States