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

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

SUBMITTER: DiMaio CJ

PROVIDER: S-EPMC5025313 | biostudies-other | 2016 Sep

REPOSITORIES: biostudies-other

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Project description:Background and study aims Traditionally in the case of a vascular interposition, endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has been contraindicated. A transvascular route (TV) is feasible and probably a safe alternative approach in selected patients, but data are scarce. The primary aim of this study was to analyze the diagnostic yield and safety of EUS-TV-FNA in thoracic and abdominal lesions. Secondary aims included evaluation of the clinical impact and technical aspects. Patients and methods A retrospective multicenter study was conducted with inclusion of all consecutive patients that underwent EUS-TV-FNA from July 2007 to January 2020. Feasibility, cytopathology, procedure details, and safety were evaluated. Univariate analysis was performed to identify variables associated with incidents, cytopathological diagnosis, and clinical impact. Results Data were collected from a total of 49 cases and 50 EUS-TV-FNAs. The aorta (n = 19) and portal system (n = 17) were the most frequently punctured. The most frequent lesions were mediastinal lymph nodes (n = 13) and pancreatic tumors (n = 11). The diagnostic yield was 86 %, and there were nondiagnostic samples in seven cases. Overall sensitivity, specificity, and accuracy were 88 % (95 %CI,0.74-0.96), 100 % (95 %CI,0.59-1), and 90 % (95 %CI,0.78-0.96), respectively. Only three incidents were detected: two mural hematomas and a self-limited bleeding of gastroduodenal artery. In most patients, there was a significant impact on clinical management (88 %). Arterial vessel and ASA-III had a trend with incidents (both, P < 0.08). Rapid on-site evlauation was found to be an independent predictor for obtaining a conclusive sample (OR 6.2; 95 %CI, 1.06-36.73, P < 0.04). Conclusions EUS-TV-FNA is feasible, seems to be safe, and can be recommended when no other targets are available, and the information obtained would impact on the clinical plan.

Project description:Background and aimsAlthough conventional EUS-guided FNA (EUS-FNA) has previously been considered first-line for sampling subepithelial lesions (SELs), variable accuracy has resulted in increased use of fine-needle biopsy (FNB) sampling to improve diagnostic yield. The primary aim of this study was to compare FNA versus FNB sampling for the diagnosis of SELs.MethodsThis was a multicenter, retrospective study to evaluate the outcomes of EUS-FNA and EUS-guided FNB sampling (EUS-FNB) of SELs over a 3-year period. Demographics, lesion characteristics, sensitivity, specificity, accuracy, number of needle passes, diagnostic adequacy of rapid on-site evaluation (ROSE), cell block accuracy, and adverse events were analyzed. Subgroup analyses were performed comparing FNA versus FNB sampling by location and diagnostic yield with or without ROSE. Multivariable logistic regression was also performed.ResultsTwo hundred twenty-nine patients with SELs (115 FNA and 114 FNB sampling) underwent EUS-guided sampling. Mean patient age was 60.86 ± 12.84 years. Most lesions were gastric in location (75.55%) and from the fourth layer (71.18%). Cell block for FNB sampling required fewer passes to achieve conclusive diagnosis (2.94 ± 1.09 vs 3.55 ± 1.55; P = .003). The number of passes was not different for ROSE adequacy (P = .167). Immunohistochemistry was more able to be successfully performed in more FNB sampling samples (69.30% vs 40.00%; P < .001). Overall, sensitivity and accuracy were superior for FNB sampling versus FNA (79.41% vs 51.92% [P = .001] and 88.03% vs 77.19% [P = .030], respectively). On subgroup analysis, sensitivity and accuracy of FNB sampling alone was superior to FNA + ROSE (79.03% vs 46.67% [P = .001] and 87.25% vs 68.00% [P = .024], respectively). There was no significant difference in diagnostic yield of FNB sampling alone versus FNB sampling + ROSE (P > .05). Multivariate analysis showed no predictors associated with accuracy. One minor adverse event was reported in the FNA group.ConclusionsEUS-FNB was superior to EUS-FNA in the diagnosis of SELs. EUS-FNB was also superior to EUS-FNA alone and EUS-FNA + ROSE. These results suggest EUS-FNB should be considered a first-line modality and may suggest a reduced role for ROSE in the diagnosis of SELs. However, a large randomized controlled trial is required to confirm our findings.

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

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