Fine Needle Biopsy of Solid Pancreatic Mass Lesions

2019-09-17 02:47:50 | BioPortfolio


This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of three different Fine Needle Biopsy needles.


Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is currently the standard method for sampling solid pancreatic masses, with a reported sensitivity for malignant cytology of 85-95%, specificity of 95-98% and diagnostic accuracy of 78-95%. Diagnostic failures 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. Selection of needle size and determination of the number of needle passes required during a procedure play a key role in the outcomes of the diagnostic procedure. 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 advantage of FNB over FNA needles is 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.

Three different types of FNB needles are currently available - reverse-bevel tip (EchoTip ProCore HD Ultrasound Biopsy Needle, Cook Medical, Bloomington, IN), 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 (6,7), there are currently no randomized trials directly comparing all three FNB needle types. Additionally, no study has demonstrated the best technique for FNB.

EUS-guided tissue acquisition can also be performed using different techniques, including the use of suction/no suction and the slow-pull technique (8-10). There are however currently no studies comparing these different tissue acquisition techniques using the different FNB needles.

Study Design


Solid Tumor


Solid pancreatic mass lesion biopsy


Not yet recruiting


Florida Hospital

Results (where available)

View Results


Published on BioPortfolio: 2019-09-17T02:47:50-0400

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Medical and Biotech [MESH] Definitions

A mass of organic or inorganic solid fragmented material, or the solid fragment itself, that comes from the weathering of rock and is carried by, suspended in, or dropped by air, water, or ice. It refers also to a mass that is accumulated by any other natural agent and that forms in layers on the earth's surface, such as sand, gravel, silt, mud, fill, or loess. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed, p1689)

Garbage, refuse, or sludge, or other discarded materials from a wastewater treatment plant, water supply treatment plant, and air pollution control facility that include solid, semi-solid, or contained material. It does not include materials dissolved in domestic sewage, irrigation return flows, or industrial discharges.

Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.

The action by which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

A phenomenon in which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (from McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

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