Comparison of Franseen versus Reverse bevel needle for endoscopic ultrasound guided fine needle biopsy of subepithelial lesions: a randomised controlled trial

Currently, endoscopic ultrasound (EUS) is considered a standard diagnostic tool for characterization of subepithelial lesions owing to its ability to determine the layer of origin, provide accurate measurements of lesion size, and enable tissue acquisition for diagnosis. However, tissue sampling through EUS-guided fine-needle aspiration (FNA) proved to be significantly inferior in this setting as compared to bite-on-bite biopsy or other mucosal incision assisted biopsy (MIAB) techniques. EUS-guided fine-needle biopsy (EUS-FNB), which typically uses a core biopsy needle and preserves the cellular architecture, has become an increasingly useful tool in the diagnostic algorithm of other abdominal lesions, such as pancreatic masses. A recent meta-analysis showed that EUS-FNB clearly outperformed EUS-FNA for tissue sampling of SELs, thus postulating a fundamental role of FNB in the diagnostic algorithm of these lesions. However, a direct comparison between different EUS-FNB devices for tissue sampling of SEL is still lacking. Hence, this study has been designed as a randomized controlled trial (RCT) comparing two different EUS-FNB needles, Franseen tip design versus reverse bevel tip design, for diagnosis of subepithelial lesions.