EUS-guided tissue sampling with a 20-gauge core biopsy needle for the characterization of gastrointestinal subepithelial lesions: A multicenter study

Background and Objective: A new 20-gauge (G) biopsy needle with a core-trap technology has been developed with a large core size and enhanced flexibility. The aim of this multicenter study was to determine the feasibility, efficacy, and safety of EUS-guided fine-needle biopsy (EUS-FNB) with the new 20G needle in diagnosing subepithelial lesions (SELs). Materials and Methods: Retrospectively collected data from consecutive patients with SELs undergoing EUS-FNB with the 20G needle at five centers were analyzed. Results: A total of 50 SELs were included. The mean lesion size was 43.1 +/- 17.5 mm. The lesion locations were esophagus (n = 1), stomach (n = 37), distal duodenum (n = 5), rectum (n = 6), and colon (n = 1). The procedure was technically feasible in all patients. Definitive diagnosis with full histological assessment including immunohistochemistry was obtained in 88% (44/50) of the patients. Considering malignant versus benign lesions, the sensitivity, specificity, positive predictive value, and negative predictive value were 85% (95% confidence interval [CI] 70.2-94.3), 100% (95% CI 58.7%-100%), 100% (95% CI 85.1%-100%), and 62.5 (95% CI 27.7-84.8), respectively. No major complications requiring additional care have been observed. Conclusions: In this multicenter study, we found that EUS-FNB with the new 20G core needle is an effective and safe method for the diagnosis of SELs with a high rate of producing adequate histological material and high diagnostic accuracy even from difficult-to-approach anatomical locations.