LAUSR

BACKGROUND & AIMS To prospectively validate the performance of spleen stiffness measurement (cut-off 46 kPa) combined with Baveno VI criteria in ruling out high-risk varices in HBV-related cirrhotic patients with maintained viral suppression. METHODS Cirrhotic patients were enrolled from April to December 2019 (ClinicalTrials.gov:NCT04123509). Liver and spleen transient elastography and esophagogastroduodenoscopy were performed at enrollment. Antiviral regimen(s) and virological responses, evaluated every 3-6 months, were recorded. RESULTS Overall 341 HBV-related cirrhotic patients with maintained viral suppression were enrolled, and the prevalence of high-risk varices was 20.5% (70/341). Baveno VI criteria spared 37.0% (126/341) of esophagogastroduodenoscopy and no high-risk varices was missed (0/70). Eight high-risk varices cases (8/70, 11.4%) were misclassified in patients (208/341, 61.0%) within the expanded Baveno VI criteria. The spleen stiffness measurement cut-off (≤46.0 kPa) was well validated in safely ruling out high-risk varices in these patients (the percentage of missed high-risk varices was 4.3%). Over half (61.6%, 210/341) of patients met the combined model (Baveno VI criteria and spleen stiffness measurement with cut-off ≤46 kPa) and 4.3% (3/70) of high-risk varices cases were misclassified. The performance of this combined model in ruling out high-risk varices exhibited a sensitivity of 95.71%, specificity of 76.38%, negative predictive value of 98.57%, and negative likelihood ratio of 0.06. CONCLUSIONS Excellent performance of Baveno VI criteria combined with spleen stiffness measurement (cut-off 46 kPa) was validated for safely ruling out high-risk varices, and spared over half of esophagogastroduodenoscopy procedures in HBV-related cirrhotic patients with maintained viral suppression.