Parotid Gland Neoplasms Clinical Trial
Official title:
Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.
This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients
with parotid gland masses referred for treatment at our center, from January 2003 to
December 2007.
The gold standard for the diagnosis of malignancy is the surgical pathology report of the
parotidectomy specimen.
Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian
analysis.
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Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic