Prospective study of EUS-guided tissue acquisition with a 20G core biopsy needle with a forward bevel for solid pancreatic mass.

Abstract

There is a growing need for tissue collection for immunostaining and genetic testing. Recently, several fine-needle biopsy needles are commercially available for endoscopic ultrasound-guided tissue acquisition.This prospective historical controlled study evaluates a 20G core biopsy needle with a forward bevel for solid pancreatic masses larger than 15 mm in diameter. The primary endpoint was the accuracy of histological diagnosis. The secondary endpoints included technical success rate, sample adequacy for histology, cytological diagnostic accuracy, and adverse events.Seventy consecutive patients were enrolled between January and October 2017. We achieved technical success in all cases regardless of the puncture sites or the endosonographer's experience. The final diagnoses were neoplasms in 67 patients (95.7%; pancreatic cancer in 65 patients, neuroendocrine neoplasm in 1, and malignant lymphoma in 1) and benign lesions in 3 patients (4.3%; autoimmune pancreatitis in 2 patients and mass-forming pancreatitis in 1). The obtained specimens were adequate for histological evaluation in all cases and the histological accuracy was 91.4% (95% confidence interval, 82.3–96.8%, P < .05) with the sensitivity and specificity of 91.0% and 100%, respectively. The cytological diagnostic accuracy was 95.7% and all patients were accurately diagnosed by combining cytological and histological examinations. As for adverse events, an asymptomatic needle fracture occurred in 1 case (1.4%).This 20G core biopsy needle with a forward bevel showed a high accuracy of histological diagnosis for solid pancreatic masses.