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

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.

Outcomes research in gastroenterology and endoscopy.

Although the field of outcomes research has received increased attention in recent years, there is still considerable uncertainty and confusion about what is "outcomes research". The following editorial is designed to provide an overview on this topic, illustrate specific examples of outcomes research in clinical gastroenterology and endoscopy, and discuss its importance as a whole. In this article, we review the definition and specific goals of outcomes research. We outline the difference between traditional clinical research and outcomes research and discuss the benefits and limitations of outcomes research. We summarize the types of outcomes studies and methods utilized for outcomes assessment, and give specific examples of the impact of outcomes studies in the field of gastroenterology and endoscopy.

Clinical impact of EUS-FNA of mediastinal lymph nodes in patients with known or suspected lung cancer or mediastinal lymph nodes of unknown etiology.

INTRODUCTION: Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) of mediastinal lymph nodes (LNs) has emerged as a valuable minimally invasive tool for staging. The objective of this study was to determine the accuracy of EUS-FNA of mediastinal LNs in patients with known or suspected non-small cell lung cancer (NSCLC) or with mediastinal LNs of unknown etiology and review its clinical impact. METHODS: A review was performed on 107 consecutive patients. If malignant cells were identified by EUS-FNA, the result was accepted as a true positive. When cytology was non-malignant, results were compared with the final surgical pathology. RESULTS: Of 79 patients with known or suspected lung cancer who had mediastinal LNs, 69 patients underwent EUS-FNA. Thirty-two received a definitive diagnosis with EUS-FNA and did not undergo further workup, while 37 patients had benign (33) or non-diagnostic FNAs (4); 26 patients further underwent surgical staging. Sensitivity, specificity, and accuracy for EUS-FNA of mediastinal LNs in patients with known or suspected lung cancer was 82.35%, 100%, and 90% respectively. The negative predictive value was 80% and the positive predictive value was 100%. There were 20 patients with suspicious mediastinal LNs of uncertain etiology, with a definitive diagnosis being made using EGD/EUS-FNA in 95%. CONCLUSION: Our data supports the use of EUS-FNA in the work-up of enlarged mediastinal LNs on cross sectional imaging, thus avoiding more invasive mediastinal sampling procedures and potentially futile surgery.

Irregular echogenic foci representing coagulation necrosis: a useful but perhaps under-recognized EUS echo feature of malignant lymph node invasion.

BACKGROUND AND AIMS: Coagulation necrosis has been described in malignant lymph nodes. Our aim was to determine if coagulation necrosis in mediastinal lymph nodes imaged by EUS could be used as a useful echo feature for predicting malignant invasion. METHODS AND DESIGN: Patients with known or suspected lung cancer who had undergone mediastinal lymph node staging by EUS. SETTING: Tertiary Care university hospital. PARTICIPANTS AND INTERVENTION: An expert endosonographer blinded to the final diagnosis, reviewed the archived digital EUS images of lymph nodes prior to being sampled by FNA. LNs positive for malignancy by FNA were included. The benign group included lymph node images with either negative EUS-FNA or lymph nodes imaged by EUS but not subjected to EUS-FNA, with surgical correlation of their benign nature. RESULTS: 24 patients were included. 8 patients were found to have coagulation necrosis. 7/8 patients had positive result for malignancy by EUS-FNA. One patient determined to have coagulation necrosis had a non-malignant diagnosis indicating a false positive result. 16 patients had no coagulation necrosis. In 6 patients with no coagulation necrosis, the final diagnosis was malignant and in the remaining 10 cases, the final diagnosis was benign. For coagulation necrosis as an echo feature for malignant invasion, sensitivity was 54%, specificity was 91%, positive predictive value was 88%, negative predictive value was 63% and accuracy was 71%. CONCLUSION: Coagulation necrosis is a useful echo feature for mediastinal lymph node staging by EUS.