Head to Head Comparison of Two Needles EUS Guided FNB

EUS guided core biopsy using various needle designs and sizes, seems to be a promising
technique to procure tissue in solid pancreatic masses for making an accurate histological
diagnosis. EUS-guided core biopsies of pancreas may aid in patients with non-diagnostic
EUS-FNA samples and institutions where they do not have on-site cytopathology available for
prompt evaluation of tissue adequacy. Making an accurate diagnosis not only assists in
planning appropriate treatment but also may decrease morbidity/mortality from unnecessary
surgeries.

Our goal is to evaluate and compare the diagnostic accuracy and specimen adequacy of the
Cook Medical 25 gauge ProCore ultrasound biopsy needle and the Medtronic (Beacon) 25 gauge
SharkCore ultrasound biopsy needle. We hypothesize the endoscopic ultrasound tissue biopsy
will not be different in diagnostic accuracy of solid pancreatic lesions when using a 25
gauge SharkCore ultrasound biopsy needle in comparison with the 25 gauge ProCore ultrasound
biopsy needle.

This is a non- inferior paired, prospective, single-blind study design in which patients
undergoing EUS for a solid pancreatic mass. Two biopsies with each of the two endoscopic
needles of interest in this study will be used in random order. The biopsy needle passed
first will be randomized, after which the two needles will be alternated for each of the
remaining biopsies. Randomization will occur in permuted blocks of 3. Physician will record
the ease/ difficulty of obtaining each of the 4 biopsies on a scale of 1 to 5. Also, they
record the needle visibility on ultrasound. The biopsy site will be examined for evidence of
bleeding. Biopsies will be sent to the pathology laboratory in a blinded fashion in coded
containers, where pathologist determine the number of adequate biopsies out of two passes of
each needle.The pathologist will also provide a scale of perceived diagnostic usefulness of
material in a blinded fashion. Post procedure care will including a letter to referring
physician with recommendations for treatment and follow up.

This study include 30 patients referred to Hershey Medical Center.

Inclusion Criteria:

- Adult subjects aged 18-90 of any gender, ethnicity and race that are referred to
endoscopy for endoscopic ultrasound guided tissue acquisition for solid pancreatic
mass.

- Voluntary enrollment

- Ability to give written informed consent

- Subjects must have a pancreatic mass detected by radiology (CT or MRI) or ultrasound
or at the time of EUS.

Exclusion Criteria:

- Patients with coagulopathy with an elevated INR>2

- Any individual who cannot provide one's voluntary informed written consent.

- Any pre-existing or discovered medical condition that may at the discretion of
investigator interfere with the completion of and/ or participation in existing
protocol.

- Pregnancy

- Less than 18 years old