Diagnosis of Bile Duct Strictures

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000999
• Other study ID #: Cytology 2013-201211068
• Status: Completed
• Start date: November 2013
• Est. completion date: January 2, 2019

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bile Duct Stricture
• Cholangiocarcinoma
• Cholestasis
• Chronic Pancreatitis
• Constriction, Pathologic
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• brushing of bile duct strictures for cytology

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	• Specimen adequacy		2 years
Secondary	• Complications (pancreatitis, bleeding, perforation, cholangitis)		2 years
Secondary	• Technical success and ease of procedure		2 years