Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)
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.
Diagnostic accuracy of needle as assessed by diagnostic yield of needle and final diagnosis method
Number of passes to procure core tissue from needle
EUS-FNB with ProCore needle
Study Arms / Comparison Groups
EUS-FNB with ProCore needle
Description: General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Patients ≥ 18 years of age referred for EUS
Lesions requiring histologic diagnosis:
- Mesenchymal tumors
- Autoimmune pancreatitis
- Granulomatous disease
- Indeterminate hepatitis
- Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine
- Solid tumors
- Previously non-diagnostic FNA
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which
is routine for all endoscopic procedures)
- Refusal to consent form
- Cystic lesions
- Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)
18 Years - 100 Years
Accepts Healthy Volunteers
Mouen Khashab, MD, ,
Johns Hopkins University
Mouen Khashab, MD, Principal Investigator, Johns Hopkins University