Fine Needle Biopsy of Solid Pancreatic Mass Lesions
Fine Needle Biopsy of Solid Pancreatic Mass Lesions
This is a randomized trial to evaluate and directly compare the tissue quality, diagnostic
 sucess and safety profile of four different Fine Needle Biopsy needles.
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard
 method for sampling solid pancreatic masses, with reported sensitivity for malignant cytology
 of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failure of
 EUS-FNA can be due to inadequate targeting, inexperience of the endoscopist/pathologist, or
 necrotic or fibrotic tumors in which viable cells are difficult to obtain. The cellularity
 and architectural representation of the sample can also be determined by the needle used and
 its specific features. Recently, new needles known as "fine needle biopsy (FNB)" needles have
 become available that are specially designed to promote the collection of core tissue by
 unique designs of their needle tips. The advantages of FNB over FNA needles are that (a) the
 quality of tissue procured is superior: FNA needles yield cytology whereas FNB needles yield
 histology (b) molecular marker analysis can be performed more reliably on histology samples
 than cytology aspirates and (c) as histological tissue is greater in quantity than
 cytological aspirates, a quicker diagnosis with fewer passes can be established by histology
 than cytology.

 Four different types of FNB needles are currently available - reverse-bevel tip (EchoTip
 ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), Menghini-tip (EZ shot,
 Olympus America, Center Valley, PA), Franseen tip (Acquire, Boston Scientific Corporation,
 Natick, MA) and fork-tip (SharkCore, Medtronic Corporation/Covidien, Newton, MA) needles,
 each with unique tip designs to facilitate procurement of histological core tissue. Although
 we have previously compared in randomized trials the diagnostic yield of Franseen and
 fork-tip FNB needles and have shown the two needles to be equivalent, there are currently no
 randomized trials directly comparing all four FNB needle types. EUS-guided tissue acquisition
 can also be performed using different techniques, including the use of suction, no use of
 suction and the stylet retraction technique. There are currently no studies comparing these
 different tissue acquisition techniques using the different FNB needles and no study has
 demonstrated the best technique for FNB.
Inclusion Criteria:

 1. All patients referred for EUS-guided tissue acquisition of suspected or confirmed
 solid pancreatic mass lesions visualized on any radiological imaging

 2. Able and willing to provide written or verbal consent

 3. ≥ 18 years old

 4. Able to undergo conscious sedation for EUS procedure

 Exclusion Criteria:

 1. <18 years old

 2. Unable to obtain informed consent from the patient

 3. Medically unfit for sedation

 4. Pregnant patients

 5. No pancreatic mass lesions visualized on EUS

 6. Irreversible coagulopathy as determined by platelet count < 50,000/microL or
 International Normalized Ratio (INR) > 1.5

 7. Unable to stop anti-platelet agents prior to the procedure