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Performance Characteristics of Vibration-Controlled Transient Elastography for Evaluation of Non-Alcoholic Fatty Liver Disease
Hepatology ( IF 13.5 ) Pub Date : 2017-11-29 , DOI: 10.1002/hep.29489
Raj Vuppalanchi 1 , Mohammad S. Siddiqui 2 , Mark L. Van Natta 3 , Erin Hallinan 3 , Danielle Brandman 4 , Kris Kowdley 5 , Brent A. Neuschwander-Tetri 6 , Rohit Loomba 7 , Srinivas Dasarathy 8 , Manal Abdelmalek 9 , Edward Doo 10 , James A. Tonascia 3 , David E. Kleiner 11 , Arun J. Sanyal 2 , Naga Chalasani 1 ,
Affiliation  

Vibration‐controlled transient elastography estimates liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), which are noninvasive assessments of hepatic fibrosis and steatosis, respectively. However, prior vibration‐controlled transient elastography studies reported high failure rates in patients with nonalcoholic fatty liver disease. We examined the performance characteristics of the FibroScan 502 Touch with two probes, medium (M+) and extra large (XL+), in patients with nonalcoholic fatty liver disease in a multicenter setting. A total of 1,696 exams were attempted in 992 patients (body mass index, 33.6 ± 6.5 kg/m2) with histologically confirmed nonalcoholic fatty liver disease. Simultaneous assessment of LSM and CAP was performed using the FibroScan 502 Touch with an automatic probe selection tool. Testing was conducted twice in patients by either a single operator (87%) or two operators (13%). Failure was defined as the inability to obtain a valid examination. An examination was considered unreliable if LSM interquartile range/median was >30%. Significant disagreement between two readings was defined as >95% limits of agreement between two readings. A total of 1,641 examinations yielded valid results with a failure rate of 3.2% (55/1,696). The proportion of unreliable scans for LSM was 3.9%. The proportion of unreliable scans with operator experience in the top quartile (≥59 procedures) was significantly lower than that in the lower three quarters combined (1.6% versus 4.7%, P = 0.02 by Fisher's exact test). The significant disagreement between first and second readings for LSM and CAP when obtained back to back was 18% and 11%, respectively. Conclusion: Vibration‐controlled transient elastography for estimation of LSM and CAP can be successfully deployed in a multicenter setting with low failure (3.2%) and high reliability (>95%) rates and high reproducibility. (Hepatology 2018;67:134‐144).

中文翻译:

振动控制瞬时弹性成像评估非酒精性脂肪肝的性能特点

振动控制的瞬时弹性成像估计肝脏硬度测量 (LSM) 和受控衰减参数 (CAP),它们分别是肝纤维化和脂肪变性的无创评估。然而,先前的振动控制瞬时弹性成像研究报告了非酒精性脂肪肝患者的高失败率。我们在多中心环境中检查了 FibroScan 502 Touch 在非酒精性脂肪肝患者中使用两种探头(中型 (M+) 和超大型 (XL+))的性能特征。对 992 名经组织学证实的非酒精性脂肪肝患者(体重指数,33.6 ± 6.5 kg/m2)进行了总共 1,696 次检查。使用带有自动探头选择工具的 FibroScan 502 Touch 对 LSM 和 CAP 进行同时评估。由一名操作员 (87%) 或两名操作员 (13%) 对患者进行了两次测试。失败被定义为无法获得有效的考试。如果 LSM 四分位距/中位数 >30%,则认为检查不可靠。两个读数之间的显着差异被定义为两个读数之间的一致性 > 95% 的限制。共有 1,641 次检查产生有效结果,失败率为 3.2% (55/1,696)。LSM 不可靠扫描的比例为 3.9%。前四分位数(≥59 次手术)中具有操作员经验的不可靠扫描的比例显着低于后四分之三的总和(1.6% 对 4.7%,Fisher 精确检验 P = 0.02)。背靠背获得时,LSM 和 CAP 的第一读数和第二读数之间的显着差异为 18% 和 11%,分别。结论:用于估计 LSM 和 CAP 的振动控制瞬态弹性成像可以成功地部署在多中心环境中,具有低故障 (3.2%) 和高可靠性 (>95%) 率和高重现性。(肝病学 2018 年;67:134-144)。
更新日期:2017-11-29
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