Efficacy of Endoscopic Ultrasound‐guided Fine Needle Biopsy With Simplified Macroscopic On‐site Evaluation (With Video)

ABSTRACT Background and Aims With advances in preoperative chemotherapy and comprehensive genomic profiling, endoscopic ultrasound‐guided fine needle biopsy (EUS‐FNB) has become vital for diagnosing pancreatic and peridigestive tract lesions. However, evidence remains limited regarding the performance of new‐generation puncture needles and simplified specimen evaluation methods. This study retrospectively assessed the diagnostic ability and procedural adverse events (AEs) of a new‐generation puncture needle for solid pancreatic, subepithelial, and other lesions. Methods We analyzed data from 1232 consecutive patients who underwent EUS‐FNB between August 2016 and November 2023 at a single care center. Specimen processing was performed using the simplified macroscopic on‐site evaluation (S‐MOSE) method, which does not require additional pathological tests such as rapid on‐site evaluation or cytology. Results The overall diagnostic accuracy using S‐MOSE was 93.7%. Specifically, the diagnostic accuracy for pancreatic cancer was 95.8%. The AE rate was 1.1% (14/1232), including pancreatitis (six), hemorrhage (five), hematoma (two), and pancreatic fistulas (one). The first puncture diagnostic rate was 83.6%, which increased to 92.5% after the second puncture, with only a marginal gain of 1.2% beyond the third puncture. Multivariable analysis identified smaller lesion size and benign pathology as factors associated with lower diagnostic accuracy; conversely, malignant pathology was associated with higher diagnostic accuracy (odds ratio 1.895, p = 0.011). Conclusion EUS‐FNB with S‐MOSE, typically requiring up to two punctures, provides efficient and accurate histopathological diagnosis across diverse lesions while minimizing procedural burden. Trial Registration : N/A.