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Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle
Sponsor: Thomas Jefferson University
Summary
The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue.
Official title: Prospective Randomized Study of Utilizing the 22-gauge Standard FNA Needle Compared to the SharkCore™ 22-gauge Fine Needle Biopsy (FNB) Needle in Patients With Solid Mass Lesions of the Gastrointestinal Tract
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2016-07
Completion Date
2017-11
Last Updated
2026-04-13
Healthy Volunteers
Yes
Interventions
22G SharkCore™ needle
The 2 dedicated passes from the SharkCore™ needle will be placed in a jar with formaldehyde-based fixative and sent for routine histopathology evaluation. The cassette will be processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist, who was blinded to the randomization sequence, for the presence of a histologic tissue. If adequate histologic tissue is present, the specimen will be graded as optimal or suboptimal.
22G BNX EUS-FNA Needle
Aspirates will be placed onto glass slides and preserved with Diff-Quik stain (American Scientific Products, McGraw Park, Illinois, USA). In addition, a smear will also be placed in alcohol for Papanicolaou staining. Any additional material was sprayed into Hanks's solution and sent for cell block processing. The cytology technician or cytopathologist on site will verify adequacy of specimens. At least two passes will be obtained from the lesion unless the technician established the presence of malignant appearing cells.
Locations (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States