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Year : 2018  |  Volume : 7  |  Issue : 1  |  Page : 34-40

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

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

Correspondence Address:
Dr. Douglas G Adler
Division of Gastroenterology and Hepatology, University of Utah School of Medicine, Huntsman Cancer Center, 30N 1900E 4R118, Salt Lake City, Utah 84132
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/eus.eus_27_17

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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 1st, 2nd, and 3rd 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.

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