Diagnosis of Bile Duct Strictures
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer, Cancer, Gastrointestinal, Gastrointestinal, Pancreatic Cancer |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 6/20/2018 |
| Start Date: | November 2013 |
| End Date: | February 2019 |
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
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.
(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.
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)
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