Clinical trial NCT02000999: Diagnosis of Bile Duct Strictures
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Stricture
Cholangiocarcinoma
Pancreatic Cancer
Chronic Pancreatitis
Keywords: Bile duct stricture
Cholangiocarcinoma
Pancreatic cancer
Chronic pancreatitis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct stricture

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.


Eligibility criteria: 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)

Primary outcomes:
measure: • Sensitivity accuracy of cytology, FISH and mutation profiling using histologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard.
timeFrame: 2 years
Secondary outcomes:
measure: • Specimen adequacy
timeFrame: 2 years
measure: • Complications (pancreatitis, bleeding, perforation, cholangitis)
timeFrame: 2 years
measure: • Technical success and ease of procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References: