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

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.

Endoscopic ultrasound‐guided tissue acquisition of solid mass lesions of the pancreas: A retrospective comparison study of fine‐needle aspiration and fine‐needle biopsy

“…Two studies with limited sample size and with ROSE performed for all procedures, reported individual yields of 77.5% and 80% for FNA and 90% and 93% for FNB, respectively . In a multicenter retrospective review of FNBs, the diagnostic yield for pancreatic lesions was 86% (when analyzed by histology) . Fitzpatrick et al also reported a diagnostic yield of 86% with FNB in a recent study involving a relatively large cohort of 179 lesions, of which 49% were pancreatic.…”

“…EUS‐FNA has been the main modality for pancreatic solid mass lesion sampling for several years with a sensitivity of 85% to 87% and a specificity of 96% to 98% . In recent years, there has been a change in the paradigm of tissue acquisition for these lesions with the emergence of next generation core biopsy needles including ProCore (Cook Medical, Bloomington, Indiana), SharkCore (Medtronic, Dublin, Ireland), and more recently, Acquire Franseen (Boston Scientific, Marlborough, Massachusetts) …”

“…However, most were limited by sample size and some included analysis of extrapancreatic lesions as well . Additionally, data regarding the impact of ROSE on the diagnostic yield of SharkCore needle varies across different studies . There is also little information about the relative efficacy of combined FNA and FNB sampling in pancreatic lesions.…”

The diagnostic and cellularity yield of reverse bevel versus fork‐tip fine needle biopsy

“…1 EUS-FNA of pancreatic lesions has diagnostic sensitivity and specificity of 64%-85% and 75%-100%, respectively, with lower diagnostic yields reported for lymph nodes and sub-epithelial lesions. 1 EUS-FNA of pancreatic lesions has diagnostic sensitivity and specificity of 64%-85% and 75%-100%, respectively, with lower diagnostic yields reported for lymph nodes and sub-epithelial lesions.…”

Endoscopy Upper

“…This arrangement is not cost‐effective and may not always be available. One review showed EUS‐FNB without on‐site cytopathology has a similar accuracy to EUS‐FNA with it, but this was not replicated in other studies . One study demonstrated that increasing the number of FNA “passes” to a minimum of seven can ameliorate the need for on‐site cytopathology without reducing diagnostic accuracy or increasing risk .…”