Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial
When ultrasound is used during endoscopy, we are able to visualize the structures adjacent
to the gastrointestinal tract in close detail. Once the mass is visualized, we use
endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order
to provide a diagnosis.
The conventional method for obtaining a sample of tissue with endoscopic ultrasound is
called fine needle aspiration (FNA). This involves the insertion of a thin needle into the
mass and obtaining a small sample of tissue which the pathologist can examine. An
alternative technique is called fine needle biopsy (FNB), and involves the insertion of a
thin double-edged needle into the mass. This double-edged needle may potentially provide a
larger sample of tissue to examine.
Both of these techniques are commonly used, and both methods are equally safe. However, it
is not known if one of these techniques is more effective at obtaining a sample of tissue or
if one of these techniques is more cost-effective than the other. The purpose of this study
is to determine if one method is more efficacious and cost-effective than the other while
maintaining diagnostic accuracy. The results of this study may alter the way
gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the
utility of the exam and reducing unnecessary healthcare costs.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Number of needle passes needed to obtain a pathologic diagnosis.
Within 1 week of study enrollment
Satish Nagula, MD
Stony Brook University
United States: Institutional Review Board
|Stony Brook University Hospital||Stony Brook, New York 11794-8174|