SharkCore Versus Acquire FNB



Status:Recruiting
Healthy:No
Age Range:18 - 85
Updated:2/1/2019
Start Date:October 29, 2018
End Date:December 2020
Contact:Henning Gerke, MD
Email:henning-gerke@uiowa.edu
Phone:319-384-6582

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Randomized Controlled Trial Comparing SharkCore FNB Needles With Acquire FNB Needles Regarding Specimen Quality and Diagnostic Accuracy

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an
effective technique for sampling tissue inside and around the gastrointestinal tract,
including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient,
minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a
specificity of 82%-100%.

Diagnosis of various pathologies in the GI tract including solid pancreatic masses,
mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal
lesions require adequate tissue architecture and immunohistochemical analysis. This is
difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core
tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with
immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle
(Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy,
tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies
have compared these two needles to see which one is better for overall diagnostic accuracy.
Our goal is to perform a prospective analysis to compare the diagnostic yield and safety
profile of these 2 new EUS needle.


Inclusion Criteria:

- Patients schedule for EUS guided biopsy

Exclusion Criteria:

- Patients who had EUS-FNA for cystic fluid aspiration

- Pregnant females

- International normalized ratio >1.5 and platelet count < 50,000

- Medically unstable
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Phone: 319-384-6582
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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