Endosc Int Open 2016; 04(09): E974-E979
DOI: 10.1055/s-0042-112581
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Christopher J. DiMaio
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
,
Jennifer M. Kolb
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
,
Petros C. Benias
2   Mount Sinai Beth Israel Medical Center, New York, New York, United States
,
Hiral Shah
3   Lehigh Valley Hospital, Allentown, Pennsylvania, United States
,
Shashin Shah
3   Lehigh Valley Hospital, Allentown, Pennsylvania, United States
,
Oleh Haluszka
4   Temple University School of Medicine, Philadelphia, Pennsylvania, United States
,
Jennifer Maranki
4   Temple University School of Medicine, Philadelphia, Pennsylvania, United States
,
Kaveh Sharzehi
4   Temple University School of Medicine, Philadelphia, Pennsylvania, United States
,
Eric Lam
5   University of British Columbia, Vancouver, British Columbia, Canada
,
Stuart R. Gordon
6   Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
,
Sarah M. Hyder
6   Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
,
Pavlos Z. Kaimakliotis
7   Lahey Clinic, Burlington, Massachusetts, United States
,
Satya B. Allaparthi
7   Lahey Clinic, Burlington, Massachusetts, United States
,
Frank G. Gress
8   NewYork-Presbyterian Hospital/Columbia University, New York, New York, United States
,
Amrita Sethi
8   NewYork-Presbyterian Hospital/Columbia University, New York, New York, United States
,
Ashish R. Shah
8   NewYork-Presbyterian Hospital/Columbia University, New York, New York, United States
,
Jose Nieto
9   Borland-Groover Clinic, Jacksonville, Florida, United States
,
Vivek Kaul
10   University of Rochester Medical Center, Rochester, New York, United States
,
Shivangi Kothari
10   University of Rochester Medical Center, Rochester, New York, United States
,
Truptesh H. Kothari
10   University of Rochester Medical Center, Rochester, New York, United States
,
Sammy Ho
11   Montefiore Medical Center, Bronx, New York, United States
,
Manhal J. Izzy
11   Montefiore Medical Center, Bronx, New York, United States
,
Neil R. Sharma
12   Parkview Health System, Wayne, Indiana, United States
,
Rabindra R. Watson
13   David Geffen School of Medicine at UCLA, Los Angeles, California, United States
,
V. Raman Muthusamy
13   David Geffen School of Medicine at UCLA, Los Angeles, California, United States
,
Douglas K. Pleskow
14   Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Tyler M. Berzin
14   Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Mandeep Sawhney
14   Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Emad Aljahdi
14   Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
,
Marvin Ryou
15   Brigham and Women’s Hospital, Boston, Massachusetts, United States
,
Clarence K. Wong
16   University of Alberta, Edmonton, Alberta, Canada
,
Parantap Gupta
17   Crystal Run Healthcare, Middletown, New York, United States
,
Dennis Yang
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
,
Susana Gonzalez
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
,
Douglas G. Adler
18   University of Utah School of Medicine, Salt Lake City, Utah, United States
› Author Affiliations
Further Information

Publication History

submitted 14 December 2015

accepted after revision 05 July 2016

Publication Date:
30 August 2016 (online)

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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