Rule-Out Cutoff of Two-Dimensional Shear Wave Elastography for Significant Fibrosis in Metabolic Dysfunction–Associated Steatotic Liver Disease: Systematic Review, Meta-Analysis, and External Validation

초록

Background & Aims Two-dimensional shear-wave elastography is a practical method for assessing liver fibrosis. However, an optimal cutoff value to rule out significant fibrosis (≥F2) in metabolic dysfunction–associated steatotic liver disease remains unclear. This study aimed to determine the evidence-based rule-out cutoff through diagnostic meta-analysis. Methods A systematic review was of MEDLINE, EMBASE, and Cochrane CENTRAL was performed through December 2025 for studies evaluating 2-dimensional shear-wave elastography with liver biopsy as the reference standard. Pooled sensitivity, specificity, and summary area under the receiver operating characteristic curve were estimated. The rule-out cutoff was defined as the highest threshold achieving pooled sensitivity ≥80%. External validation was performed using an independent clinical cohort. Results Twenty-two studies involving 3171 adults with biopsy-proven metabolic dysfunction–associated steatotic liver disease were analyzed. The summary area under the receiver operating characteristic curve was 0.84 (95% confidence interval, 0.81–0.87), with pooled sensitivity of 79.6% and specificity of 76.0%. The rule-out cutoff of 6.6 kPa (95% confidence interval, 5.4–8.2 kPa) achieved sensitivity of 80.0% and specificity of 70.7%. At this threshold, negative predictive value exceeded 95% at prevalences of 5% and 10%. Diagnostic performance was generally preserved across subgroups but was modestly attenuated in populations with greater metabolic burden and in studies using Supersonic ultrasound platforms. External validation (N = 163) demonstrated consistent sensitivity (0.86) and specificity (0.68). Conclusions Two-dimensional shear-wave elastography demonstrated good diagnostic accuracy for significant fibrosis in metabolic dysfunction–associated steatotic liver disease. A liver stiffness of 6.6 kPa can reliably rule out significant fibrosis. As 2-dimensional shear-wave elastography can be integrated into conventional ultrasound systems, it may facilitate broader implementation of fibrosis screening beyond specialized centers. Clinical trial number: PROSPERO (International Prospective Register of Systematic Reviews), CRD42024616042.

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