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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02000999
Other study ID # Cytology 2013-201211068
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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