超声剪切波和瞬时弹性成像在非酒精性脂肪性肝病中的可重复性和再现性。
Reproducibility and Repeatability of US Shear-Wave and Transient Elastography in Nonalcoholic Fatty Liver Disease.
机构信息
From the Center for Ultrasound Research and Translation, Massachusetts General Hospital, 55 Fruit St, White Bldg, Rm 270, Boston, MA 02114 (T.T.P., A.O., X.W., Q.L., D.H., M.M., H.E., A.E.S.); Harvard Medical School, Boston, Mass (T.T.P., A.O., Q.L., A.E.S.); Pfizer, Cambridge, Mass (S.P.S.); Department of Radiology, University of Washington, Seattle, Wash (G.M.C.); Department of Ultrasound, Shenzhen University General Hospital, Shenzhen, China (Q.L.); Department of Radiology, Liver Imaging Group, University of California San Diego, La Jolla, Calif (M.S.M., Y.C., C.B.S., K.J.F.); MGH Fatty Liver Program, Gastrointestinal Unit, Massachusetts General Hospital, Boston, Mass (K.E.C.); BioAge Labs, Richmond, Calif (S.S.S.); Foundation for the National Institutes of Health, North Bethesda, Md (H.H., T.N.K.); Regeneron Pharmaceuticals, Tarrytown, NY (R.A.C.); Department of Medicine, Division of Gastroenterology, NAFLD Research Center, University of California at San Diego, La Jolla, Calif (R.L.); Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); and Department of Internal Medicine, Division of Internal Medicine, Division of Gastroenterology, Virginia Commonwealth University Medical Center, Richmond, Va (A.J.S.).
出版信息
Radiology. 2024 Sep;312(3):e233094. doi: 10.1148/radiol.233094.
Background US shear-wave elastography (SWE) and vibration-controlled transient elastography (VCTE) enable assessment of liver stiffness, an indicator of fibrosis severity. However, limited reproducibility data restrict their use in clinical trials. Purpose To estimate SWE and VCTE measurement variability in nonalcoholic fatty liver disease (NAFLD) within and across systems to support clinical trial diagnostic enrichment and clinical interpretation of longitudinal liver stiffness. Materials and Methods This prospective, observational, cross-sectional study (March 2021 to November 2021) enrolled adults with NAFLD, stratified according to the Fibrosis-4 (FIB-4) index (≤1.3, >1.3 and <2.67, ≥2.67), at two sites to assess SWE with five US systems and VCTE with one system. Each participant underwent 12 elastography examinations over two separate days within 1 week, with each day's examinations conducted by a different operator. VCTE and SWE measurements were reported in units of meters per second. The primary end point was the different-day, different-operator reproducibility coefficient (RDC) pooled across systems for SWE and individually for VCTE. Secondary end points included system-specific RDC, same-day, same-operator repeatability coefficient (RC), and between-system same-day, same-operator reproducibility coefficient. The planned sample provided 80% power to detect a pooled RDC of less than 35%, the prespecified performance threshold. Results A total of 40 participants (mean age, 60 years ± 10 [SD]; 24 women) with low ( = 17), intermediate ( = 15), and high ( = 8) FIB-4 scores were enrolled. RDC was 30.7% (95% upper bound, 34.4%) for SWE and 35.6% (95% upper bound, 43.9%) for VCTE. SWE system-specific RDC varied from 24.2% to 34.3%. The RC was 21.0% for SWE (range, 13.9%-35.0%) and 19.6% for VCTE. The SWE between-system same-day, same-operator reproducibility coefficient was 52.7%. Conclusion SWE met the prespecified threshold, RDC less than 35%, with VCTE having a higher RDC. SWE variability was higher between different systems. These estimates advance liver US-based noninvasive test qualification by defining expected variability, establishing that serial examination variability is lower when performed with the same system, and informing clinical trial design. ClinicalTrials.gov Identifier NCT04828551 © RSNA, 2024
背景 美国剪切波弹性成像（SWE）和振动控制瞬态弹性成像（VCTE）可评估肝硬度，这是纤维化严重程度的一个指标。然而，有限的可重复性数据限制了它们在临床试验中的应用。目的 为了支持临床试验中对纤维化的诊断富集和对肝硬度的纵向临床解读，本研究旨在评估非酒精性脂肪性肝病（NAFLD）患者中 SWE 和 VCTE 在不同系统内和系统间的测量变异性。材料与方法 这是一项前瞻性、观察性、横断面研究（2021 年 3 月至 2021 年 11 月），在两个地点招募了 NAFLD 患者，根据纤维化 4 指数（FIB-4）（≤1.3、＞1.3 且＜2.67、≥2.67）进行分层，以评估五种 US 系统的 SWE 和一种系统的 VCTE。每位参与者在一周内的两天内进行 12 次弹性成像检查，每天的检查由不同的操作人员进行。VCTE 和 SWE 测量以米每秒为单位报告。主要终点是不同天、不同操作人员的 SWE 跨系统重复性系数（RDC）的汇总值，以及 VCTE 的个体值。次要终点包括系统特异性 RDC、同天、同操作人员重复性系数（RC）和跨系统同天、同操作人员重复性系数。计划的样本提供了 80%的效能来检测到低于 35%的汇总 RDC，这是预先规定的性能阈值。结果 共纳入 40 名参与者（平均年龄 60 岁±10[标准差]；24 名女性），低（ = 17）、中（ = 15）和高（ = 8）FIB-4 评分的患者。SWE 的 RDC 为 30.7%（95%上限为 34.4%），VCTE 的 RDC 为 35.6%（95%上限为 43.9%）。SWE 系统特异性 RDC 从 24.2%到 34.3%不等。SWE 的 RC 为 21.0%（范围为 13.9%至 35.0%），VCTE 的 RC 为 19.6%。SWE 的跨系统同日、同操作人员重复性系数为 52.7%。结论 SWE 符合预先规定的阈值，RDC 小于 35%，而 VCTE 的 RDC 更高。SWE 的变异性在不同系统之间更高。这些估计通过 定义预期的变异性、 确立当使用相同的系统进行连续检查时变异性更低、 和 为临床试验设计提供信息，推进了基于肝脏 US 的非侵入性检测的资格认证。ClinicalTrials.gov 标识符 NCT04828551 © RSNA，2024
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