Trial Information

Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms

Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate
endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided
fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for
pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a
clear relationship between cellular elements and stroma which may be required for accurate
diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for
optimal yield which limits its dissemination and increases its cost. A novel EUS histology
needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate
diagnosis without the need for on site cytopathology assistance. Aim: To prospectively
compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA
and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all
primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of
solid pancreatic tumors will be screened for enrollment at either a preceding clinical
encounter or the morning of their scheduled procedure. English-speaking patients between the
ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas
will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly
cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo
both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care.
The results of the experimental approach (EUS-FNB) will be compared to the control approach
(EUS-FNA). Data collected for each procedure will include: instrument use order, number of
needle passes with each device, technical success of each device, complications, ease of
use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data
category will then be compared utilizing standard statistical tests including chi-squared,
Fishers' exact, or student's t test.