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
Verified date | May 2019 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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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