A PROSPECTIVE CLINICAL TRIAL OF EUS-SHEAR WAVE MEASUREMENT OF LIVER AND SPLEEN FOR HEPATIC FIBROSIS.

BACKGROUND AND AIMS: Endosonographic shear wave measurement (EUS-SWM) is a novel method for assessing hepatic fibrosis. We assessed its diagnostic accuracy, reproducibility, and the impact of transducer pressure. Additionally, EUS-SWM of the spleen was performed to assess correlation with liver fibrosis. METHODS: Between January and October 2025, this single-center prospective clinical trial enrolled patients undergoing EUS-guided liver biopsy for concomitant EUS-SWM of the liver and spleen. Measurements of both hepatic lobes were obtained using standard and excessive transducer pressure. For each site, ten elasticity measurements (E-values) were acquired, with reliability defined as a velocity signal-to-noise ratio (VsN) >60%. Histologic fibrosis served as the reference standard. Statistical analyses included paired t-tests, Pearson correlation, and AUROC evaluation for fibrosis staging. RESULTS: EUS-SWM in 109 (mean age 58 ± 15.9 years; 63 women) participants demonstrated that E-values from both hepatic lobes correlated strongly with histologic fibrosis (left lobe r=0.837-0.872; right lobe r=0.748-0.766). Right lobe measurements showed higher VsN than the left lobe (93.6±8.9 vs 84.1±8.8; p<0.001). Excessive transducer pressure reduced left lobe E-values (p=0.02) but did not affect right lobe measurements or VsN in either lobe. Splenic stiffness was consistently higher than hepatic stiffness (30.1±7.8 kPa; p<0.01) and demonstrated excellent diagnostic performance for cirrhosis (AUC 0.962). For F2-F3 fibrosis, hepatic SWM achieved moderate accuracy, outperforming splenic SWM. EUS-SWM exceeded the diagnostic accuracy of APRI and FIB4 for cirrhosis detection. Operator experience did not significantly influence measurement reliability under standard pressure. CONCLUSION: EUS-SWM has excellent accuracy for cirrhosis and correlates with histologic fibrosis. Although left lobe measurements are less reliable, overall diagnostic performance is comparable across lobes, and excess transducer pressure has minimal impact. Splenic SWM adds value for detecting cirrhosis but not intermediate fibrosis.