Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

Abstract

Introduction: To evaluate the diagnostic performance of ultrasound attenuation parameter (UAP) and liver stiffness measurement (LSM) by FibroTouch for diagnosis of hepatic steatosis and fibrosis in patients with nonalcoholic fatty liver disease (NAFLD).

Methods: We recruited 237 patients undergoing FibroTouch and liver biopsy within 2 weeks. The pathological findings of liver biopsy were scored by Nonalcoholic Steatohepatitis Clinical Research Network, and the diagnostic accuracy of UAP for steatosis and LSM for fibrosis was evaluated by area under the receiver operating characteristic curve (AUROC). The impacts of histological parameters on UAP and LSM were analyzed, and diagnostic performance of FibroTouch UAP and LSM was compared with other noninvasive biomarkers.

Results: The success rate of FibroTouch examination was 96.51%. The AUROC of UAP for diagnosis of steatosis ≥S1, ≥S2, and S3 was 0.88, 0.93, and 0.88, and the cutoff values were 244, 269, and 296 dB/m, respectively. The AUROC of LSM for the diagnosis of fibrosis stages ≥F2, ≥F3, and F4 was 0.71, 0.71, and 0.77, and the cutoff values were 9.4, 9.4, and 11 kPa, respectively. Multiple regression analysis showed that LSM was positively correlated with degree of fibrosis and NAFLD activity score. UAP was positively correlated with liver steatosis. The diagnostic performance of UAP for steatosis was significantly superior to that of the hepatic steatosis index.

Discussion: FibroTouch has a low failure rate with moderate to high diagnostic performance for discriminating the steatosis degree and fibrosis stage and is suitable for clinical evaluation and monitoring of patients with NAFLD.

Trial registration: ClinicalTrials.gov NCT02456766.

Conflict of interest statement

Guarantors of the article: Lun-Gen Lu, MD, and Jian-Gao Fan, MD.

Specific author contributions: Ying Qu, MD, and Yan-Yan Song, PhD, contributed equally to this article. L.-G.L. and J.-G.F.: had the original concept and contributed to the design of the study protocol. C.-W.C., Q.-C.F., J.-P.S., Y.X., Q.X., Y.-F.Y., Y.-J.Z., L.-P.L., M.-Y.X., X.-B.C., and Q.-D.Z.: assisted recruiting sites. Y.Q. and Y.-Y.S.: performed the study and generated all data for the manuscript. Y.-Y.S. and H.Y.: performed the statistical analysis. Y.Q. and L.-G.L.: drafted the manuscript. All authors approved the final version.

Financial support: This study/project is supported by the National Science and Technology Major Project of China (2017ZX10202203-007-005) and the National Science and Technology Major Special Project for Drug Development (No.2018ZX09201016); FibroTouch-FT5000 of iLivTouch series are offered by Wuxi Hisky Medical Technologies, China. The views expressed are those of the authors.

Potential competing interests: None to report.

Trial registration: ClinicalTrials.gov NCT02456766.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.

Figures

Figure 1.

Flow chart of study design and patient enrollment. Of 270 patients enrolled, 12 were eligible, 258 had the FibroTouch examination performed, and 249 had a valid FibroTouch examination. Twelve cases had unqualified biopsy samples. Eventually, 237 patients had a valid UAP and LSM with liver biopsy. IQR, interquartile range; LSM, liver stiffness measurement; UAP, ultrasound attenuation parameter.

Figure 2.

Receiver operating characteristic (ROC) curve of ultrasound attenuation parameter (UAP) for identifying hepatic steatosis ≥S1 (a), ≥S2 (b), and S3 (c). Box plots of UAP and hepatic steatosis grade (Student–Newman–Keuls for paired comparisons, both statistically significant, P < 0.0001) (d).

Figure 3.

Comparison of AUROC of UAP and HSI for diagnosis of hepatic steatosis groups ≥S1 (a), ≥S2 (b), and S3 (c). AUROC, area under the receiver operating characteristic curve; HSI, hepatic steatosis index; UAP, ultrasound attenuation parameter.

Figure 4.

Receiver operating characteristic (ROC) curve of liver stiffness measurement (LSM) for identifying liver fibrosis ≥F2 (a), ≥F3 (b), and F4 (c). Box plot of a LSM vs fibrosis stage (Student-Newman-Keuls comparison showed that differences between F1 and F3, F1, and F4 were statistically significant) (d).