Macroscopic on-site evaluation (MOSE) has gained interest as a practical tool for assessing tissue adequacy during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). Recently, a new Franseen FNB needle was developed for EUS-TA, the SonoTip TopGain from Medi-Globe. This study aimed to assess the diagnostic performance and safety of MOSE-guided EUS-FNB using the SonoTip TopGain FNB needle across high-volume international centers.

This retrospective, multicenter study included 95 patients from nine international referral centers who underwent EUS-FNB with MOSE between May 2024 and January 2025. Inclusion criteria comprised adults (>18 years) with predominantly solid lesions undergoing EUS-FNB using the SonoTip TopGain FNB needle (22G or 25G) and without concurrent ROSE. Data on demographics, lesion characteristics, procedural details, and final histopathologic outcomes were collected. Biopsy adequacy was determined by endosonographers based on the presence of visible cores on macroscopic inspection.

The mean patient age was 65.2 ± 12.0 years, with 53 males (55.8%). Most lesions were pancreatic (67.4%), with a mean size of 31.5 ± 16.9 mm. The slow-pull technique was predominantly used, with 92 procedures (96.8%) employing a 22G needle. MOSE identified visible cores in 92 cases (96.8%). Of the 95 specimens, 6 (6.3%) were inconclusive. Cytology confirmed all 75 malignant cases (100%) and 14 of 20 benign cases (70%). Diagnostic performance for MOSE-positive samples demonstrated a sensitivity of 100%, specificity of 50%, positive predictive value of 96.7%, negative predictive value of 100%, and overall accuracy of 96.7%. Adverse events were minimal (3.2%).

MOSE using the SonoTip TopGain FNB needle demonstrates high diagnostic accuracy and excellent sensitivity for detecting malignancy, with a favorable safety profile. These findings support its utility as a reliable tool for real-time adequacy assessment in clinical practice.