Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions



Status:Completed
Conditions:Lymphoma, Endocrine, Gastrointestinal
Therapuetic Areas:Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:December 2011
End Date:December 2014
Contact:Satish Nagula, M.D.
Email:satish.nagula@stonybrookmedicine.edu
Phone:631-444-2119

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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

The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is
more efficacious and cost-effective than the other while maintaining diagnostic accuracy in
the setting of solid gastrointestinal lesions.

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.

Inclusion Criteria:

- Consecutive adult patients who require endoscopic ultrasound and tissue sampling of
either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus,
stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion
located adjacent to the esophagus, stomach, duodenum or rectum

- Ability to give consent

Exclusion Criteria:

- Inability to obtain informed consent

- Pregnant patients

- Patients under the age of 18

- Severe cardiopulmonary disease preventing a safe EUS procedure

- Patients unable to safely stop anti-coagulation therapy prior to EUS procedure
We found this trial at
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Stony Brook, New York 11794
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