Biopsy, Fine-Needle Clinical Trial
Official title:
Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet
The purpose of this study is to determine that there is no difference in final diagnosis of FNA specimens without a stylet, compared to using a stylet, when examined by a skilled cytopathologist.
Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is a highly accurate method
for cytologic diagnosis of malignancy and is routinely performed to diagnose and stage
pancreatobiliary, esophageal, gastric, rectal malignancies and subepithelial
gastrointestinal lesions. There are variations in EUS-FNA technique including the use of
suction, the area of the lesion to target (center versus periphery), gauge of needle, and
use of a stylet.
The stylet is a metal wire which is included in the needle assembly. The use of a stylet is
used purely for mechanical purposes, not for the protection or safety of the patients. It is
thought that the stylet prevents the needle from becoming clogged with gastrointestinal
epithelial cells or mucus. To our knowledge, comparing the diagnostic accuracy of EUS-FNA
with a stylet to the accuracy without a stylet has not been studied.
The optimal technique for EUS-FNA has not been established. The reported accuracy rate of
EUS-FNA (which contains heterogeneous sampling techniques, including with and without a
stylet) is 71-98% for pancreatic masses, 90% for lymph nodes, and 67-92% for submucosal
gastrointestinal lesions. Typically, FNA is performed with or without a stylet using a 22
gauge or 25 gauge needle with similar diagnostic accuracy.
When the target lesion is identified, the needle is advanced through the gastrointestinal
wall into the lesion under ultrasound guidance. If a stylet is being used, it is removed at
this point. A 10 cc syringe under suction is then placed on the end of the needle assembly
and the needle is moved back and forth within the lesion to gather cells. The assembly is
then removed and the needle contents are expelled onto slides and into preservative media.
The stylet is then reinserted and the needle assembly is advanced through the scope for
another pass. In the absence of on-site cytopathology, 7 passes with or without a stylet of
a solid lesion and 5 passes of lymph nodes with or without a stylet are recommended to
achieve high diagnostic accuracy.
EUS-FNA is time consuming, mainly because the stylet needs to be carefully reinserted
through the needle prior to each pass. Theoretically, the use of a stylet prevents clogging
of the needle with gastrointestinal epithelial cells and mucus which can affect the adequacy
of the specimen. However, there are no data to support this. As such there is a variation in
practice patterns, with some endosonographers who routinely use a stylet and those that do
not. Additionally, those who perform percutaneous FNA frequently do so using needles that do
not have a stylet. A recent study suggests that the use of a stylet improves diagnostic
accuracy in percutaneous FNA of thyroid lesions. To our knowledge, there have been no
studies assessing the use of a stylet on tissue adequacy in EUS-guided FNA.
If the practice of using a stylet during EUS-guided FNA is found to yield the same number of
adequate tissue samples as those done without a stylet, then the use of a stylet would be an
unnecessary. As stylet replacement is the most time consuming step in FNA, the time of the
procedure could be shortened significantly if the stylet is not required.
We propose a randomized controlled trial of EUS guided FNA with and without stylet which
will help determine whether the use of a stylet is integral in obtaining adequate tissue
aspirates in the diagnosis of solid lesions. To our knowledge, there have been no
prospective, randomized studies addressing the effect of the presence or absence of a stylet
on specimen adequacy during EUS-guided FNA.
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Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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