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Endosc Int Open. 2016 Sep;4(9):E974-9. doi: 10.1055/s-0042-112581. Epub 2016 Aug 30.

Initial experience with a novel EUS-guided core biopsy needle (SharkCore): results of a large North American multicenter study.

Author information

1
Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, Mount Sinai Medical Center, New York, New York, United States.
2
Mount Sinai Beth Israel Medical Center, New York, New York, United States.
3
Lehigh Valley Hospital, Allentown, Pennsylvania, United States.
4
Temple University School of Medicine, Philadelphia, Pennsylvania, United States.
5
University of British Columbia, Vancouver, British Columbia, Canada.
6
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States.
7
Lahey Clinic, Burlington, Massachusetts, United States.
8
NewYork-Presbyterian Hospital/Columbia University, New York, New York, United States.
9
Borland-Groover Clinic, Jacksonville, Florida, United States.
10
University of Rochester Medical Center, Rochester, New York, United States.
11
Montefiore Medical Center, Bronx, New York, United States.
12
Parkview Health System, Wayne, Indiana, United States.
13
David Geffen School of Medicine at UCLA, Los Angeles, California, United States.
14
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States.
15
Brigham and Women's Hospital, Boston, Massachusetts, United States.
16
University of Alberta, Edmonton, Alberta, Canada.
17
Crystal Run Healthcare, Middletown, New York, United States.
18
University of Utah School of Medicine, Salt Lake City, Utah, United States.

Abstract

BACKGROUND AND AIMS:

The ability to safely and effectively obtain sufficient tissue for pathologic evaluation by using endoscopic ultrasound (EUS) guidance remains a challenge. Novel designs in EUS needles may provide for improved ability to obtain such core biopsies. The aim of this study was to evaluate the diagnostic yield of core biopsy specimens obtained using a novel EUS needle specifically designed to obtain core biopsies.

PATIENTS AND METHODS:

Multicenter retrospective review of all EUS-guided fine-needle biopsies obtained using a novel biopsy needle (SharkCore FNB needle, Medtronic, Dublin, Ireland). Data regarding patient demographics, lesion type/location, technical parameters, and diagnostic yield was obtained.

RESULTS:

A total of 250 lesions were biopsied in 226 patients (Median age 66 years; 113 (50 %) male). Median size of all lesions (mm): 26 (2 - 150). Overall, a cytologic diagnosis was rendered in 81 % specimens with a median number of 3 passes. When rapid onsite cytologic evaluation (ROSE) was used, cytologic diagnostic yield was 126/149 (85 %) with a median number of 3 passes; without ROSE, cytologic diagnostic yield was 31/45 (69 %, P = 0.03) with a median number of 3 passes. Overall, a pathologic diagnosis was rendered in 130/147 (88 %) specimens with a median number of 2 passes. Pathologic diagnostic yield for specific lesion types: pancreas 70/81 (86 %), subepithelial lesion 13/15 (87 %), lymph node 26/28 (93 %). Ten patients (10/226, 4 %) experienced adverse events: 4 acute pancreatitis, 5 pain, 1 fever/cholangitis.

CONCLUSIONS:

Initial experience with a novel EUS core biopsy needle demonstrates excellent pathologic diagnostic yield with a minimum number of passes.

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