Prospective international multicenter evaluation of a novel 22G histology EUS needle in patients with solid pancreatic masses J.W. Poley1, M. Giovannini2 , , J.Iglesias-Garcia3, A. Larghi4, M.C. Petrone5, G. Costamagna4, Paolo Arcidiaccono5, E. Bories2, M.J. Bruno1 Department of Gastroenterology & Hepatology, Erasmus MC, Rotterdam1, Endoscopy Unit, Institute Paoli-Calmettes, Marseille, France2, Department of Gastroenterology, University Hospital of Santiago de Compostela, Spain3, Digestive Endoscopy Unit, Catholic University Rome, Italy4, Department of Gastroenterology, San Raffaele University, Milan, Italy5 Aim: To evaluate a novel 22-G histology EUS needle and to assess its diagnostic accuracy in patients with a solid pancreatic mass. Patients and Methods: Consecutive patients with a solid pancreatic mass were enrolled in a prospective study in 5 European EUS centers. Patients underwent EUS examination using a convex array echoendoscope. EUS fine needle biopsy (FNB) was performed with a newly developed 22-G Echo Tip ProCore needle from Cook Medical Inc, Limerick Ireland. EUS-FNB.. After the lesion was targeted the stylet was removed and suction was applied for 10 to 20 seconds using a 10 mL syringe while moving the needle to and fro one to four times. Suction was released before removing the needle. Only a single pass was performed. The specimen was recovered in cytolit or formalin and further processed for histological analysis. A final diagnosis of malignancy or benignancy was based on definite surgical pathology or clinical follow-up including repeated imaging examinations. Results: A total of 61 patients (35M & 26F, mean age 59.2 years, range 34-85) with a solid pancreatic mass were enrolled. Lesions were located in the uncinate process (4 cases), in the head (31 cases), in the body (17 cases), and in the tail (9 cases). Mean size of the pancreatic masses was 32 mm (range 13-90 mm). Core biopsies were obtained in 55/61 cases (90.1%). The final histologic diagnosis obtained with the 22G Echo Tip -ProCore needle was pancreatic adenocarcinoma in 39 cases, endocrine tumor in 5 cases, other malignant pancreatic mass in 5 cases including 2 pancreatic sarcomas, 1 pancreatic metastasis from a lung cancer, 1 pancreatic acinar cell carcinoma, 1 pancreatic lymphoma, and a benign nodule of chronic pancreatitis in 5 cases. EUS-FNB was inconclusive in 7 patients in whom a second EUS-FNA using a cytological needle (3 patients) or the surgical specimen (4 patients) showed a pancreatic adenocarcinoma in all cases. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy for the histologic diagnostic of a pancreatic mass using the new 22G Echo Tip ProCore needle were 87.5%, 100%, 100%, 41.7% and 88.5%, respectively. No complication occurred during the study. Conclusions: The novel 22G Echo Tip ProCore EUS needle yielded histologic tissue specimens in 90% of patients with a solid pancreatic mass. Histologic evaluation enabled differentiation of various benign and malignant pancreatic lesions, including subtyping of pancreatic lymphoma and sarcoma, with an overall accuracy of 87.5%. The limited negative predictive value in the present series might be improved by increasing the number of needle passes to 2 or 3.
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