Lymphoma Clinical Trial
Official title:
Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore): A Prospective Randomized, Controlled Multicenter Study
Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.
Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB)
have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of
the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including
lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain
neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological
examinations are needed to provide accurate diagnoses.
ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to
obtain histological and cytological samples. Studies comparing ProCore needles with standard
FNA needles showed no significant difference in diagnostic accuracy, histological core
tissue procurement or mean number of passes.
To overcome the above mentioned limitations (mainly suboptimal core tissue procurement
rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed
and approved for clinical human use by the FDA.
The objective of the study is to compare the new EUS guided histology biopsy needle
SharkCore to the currently used EUS histology needle, ProCore, for the histological
diagnosis and evaluation of lesions.
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