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Comparison of On-Site Verus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct


N/A
18 Years
89 Years
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Comparison of On-Site Verus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct


The diagnostic accuracy rate of cholangioscopy-guided biopsy is only 50%. This translates to
the need for performing repeat procedures to establish a diagnosis and therefore delays
patient treatment. The biopsy specimen obtained at cholangioscopy are usually processed in
an offsite pathology lab. We believe that if a pathologist can assess the tissue sample
during the procedure itself (onsite) and provide feedback, the diagnostic accuracy rate will
improve. This translates to better (faster) diagnosis and early treatment. Therefore, we
will be comparing onsite versus offsite evaluation of bile duct biopsy specimens to
determine which method yields a better diagnosis.


Inclusion Criteria:



- All patients referred to Florida Hospital Endoscopy Unit for assessment of bile duct
masses that require cholangioscopy-guided biopsies.

Exclusion Criteria:Age <19 years

- Unable to safely undergo EUS for any reason

- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)

- Unable to consent

- Non-English speaking patients.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

confirmation of cancer

Outcome Description:

The primary endpoint of the study is to compare the diagnostic accuracy, or confirmation of cancer rates between two different methods used for processing specimens obtained from the bile duct.

Outcome Time Frame:

up to12 months

Safety Issue:

No

Principal Investigator

Shyam Varadarajulu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Florida Hospital

Authority:

United States: Institutional Review Board

Study ID:

409832

NCT ID:

NCT01815619

Start Date:

February 2013

Completion Date:

February 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location
Florida Hospital Orlando, Florida  32803