A Multicenter comparative trial of a novel EUS-guided core biopsy needle (SharkCore™) with the 22-gauge needle in patients with solid pancreatic mass lesions

Mariam Naveed; Ali A Siddiqui; Thomas E Kowalski; David E Loren; Ammara Khalid; Ayesha Soomro; Syed M Mazhar; Joseph Yoo; Raza Hasan; Silpa Yalamanchili; Nicholas Tarangelo; Linda J Taylor; Douglas G Adler

doi:10.4103/eus.eus_27_17

A Multicenter comparative trial of a novel EUS-guided core biopsy needle (SharkCore^™) with the 22-gauge needle in patients with solid pancreatic mass lesions

Endosc Ultrasound. 2018 Jan-Feb;7(1):34-40. doi: 10.4103/eus.eus_27_17.

Affiliations

¹ Division of Gastroenterology and Hepatology, University of Iowa, Iowa City, IA, USA.
² Division of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, PA, USA.
³ Division of Gastroenterology and Hepatology, University of Utah, Salt Lake City, UT, USA.

Abstract

Background and objectives: The ability to obtain adequate tissue of solid pancreatic lesions by EUS-guided remains a challenge. The aim of this study was to compare the performance characteristics and safety of EUS-FNA for evaluating solid pancreatic lesions using the standard 22-gauge needle versus a novel EUS biopsy needle.

Methods: This was a multicenter retrospective study of EUS-guided sampling of solid pancreatic lesions between 2009 and 2015. Patients underwent EUS-guided sampling with a 22-gauge SharkCore (SC) needle or a standard 22-gauge FNA needle. Technical success, performance characteristics of EUS-FNA, the number of needle passes required to obtain a diagnosis, diagnostic accuracy, and complications were compared.

Results: A total of 1088 patients (mean age = 66 years; 49% female) with pancreatic masses underwent EUS-guided sampling with a 22-gauge SC needle (n = 115) or a standard 22-gauge FNA needle (n = 973). Technical success was 100%. The frequency of obtaining an adequate cytology by EUS-FNA was similar when using the SC and the standard needle (94.1% vs. 92.7%, respectively). The sensitivity, specificity, and diagnostic accuracy of EUS-FNA for tissue diagnosis were not significantly different between two needles. Adequate sample collection leading to a definite diagnosis was achieved by the 1^st, 2^nd, and 3^rd pass in 73%, 92%, and 98% of procedures using the SC needle and 20%, 37%, and 94% procedures using the standard needle (P < 0.001), respectively. The median number of passes to obtain a tissue diagnosis using the SC needle was significantly less as compared to the standard needle (1 and 3, respectively; P< 0.001).

Conclusions: The EUS SC biopsy needle is safe and technically feasible for EUS-FNA of solid pancreatic mass lesions. Preliminary results suggest that the SC needle has a diagnostic yield similar to the standard EUS needle and significantly reduces the number of needle passes required to obtain a tissue diagnosis.

Keywords: EUS; FNA; core; fine-needle biopsy; pancreatic mass.