Real-Time Shear Wave versus Transient Elastography for Predicting Fibrosis: Applicability, and Impact of Inflammation and Steatosis. A Non-Invasive Comparison

PLoS One. 2016 Oct 5;11(10):e0163276. doi: 10.1371/journal.pone.0163276. eCollection 2016.

Abstract

Background and aims: Real-time shear wave elastography (2D-SWE) is a two-dimensional transient elastography and a competitor as a biomarker of liver fibrosis in comparison with the standard reference transient elastography by M probe (TE-M). The aims were to compare several criteria of applicability, and to assess inflammation and steatosis impact on elasticity values, two unmet needs.

Methods: We took FibroTest as the fibrosis reference and ActiTest and SteatoTest as quantitative estimates of inflammation and steatosis. After standardization of estimates, analyses used curve fitting, quantitative Lin concordance coefficient [LCC], and multivariate logistic regression.

Results: A total of 2,251 consecutive patients were included. We validated the predetermined 0.2 kPa cut-off as a too low minimal elasticity value identifying not-reliable 2D-SWE results (LCC with FibroTest = 0.0281[-0.119;0.175]. Other criteria, elasticity CV, body mass index and depth of measures were not sufficiently discriminant. The applicability of 2D-SWE (95%CI) 89.6%(88.2-90.8), was significantly higher than that of TE, 85.6%(84.0-87.0; P<0.0001). In patients with non-advanced fibrosis (METAVIR F0F1F2), elasticity values estimated by 2D-SWE was less impacted by inflammation and steatosis than elasticity value estimated by TE-M: LCC (95%CI) 0.039 (0.021;0.058) vs 0.090 (0.068;0.112;P<0.01) and 0.105 (0.068;0.141) vs 0.192 (0.153;0.230; P<0.01) respectively. The three analyses methods gave similar results.

Conclusions: Elasticity results including very low minimal signal in the region of interest should be considered not reliable. 2D-SWE had a higher applicability than TE, the reference elastography, with less impact of inflammation and steatosis especially in patients with non-advanced fibrosis, as presumed by blood tests.

Trial registration: ClinicalTrials.gov NCT01927133.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Area Under Curve
  • Biomarkers / blood
  • Elasticity Imaging Techniques / methods*
  • Fatty Liver / diagnostic imaging*
  • Fatty Liver / epidemiology
  • Fatty Liver / pathology
  • Female
  • Humans
  • Inflammation / diagnostic imaging*
  • Inflammation / pathology
  • Liver Cirrhosis / diagnosis*
  • Liver Cirrhosis / diagnostic imaging
  • Male
  • Middle Aged
  • Multivariate Analysis
  • ROC Curve
  • Severity of Illness Index

Substances

  • Biomarkers

Associated data

  • ClinicalTrials.gov/NCT01927133

Grants and funding

This work was funded in part by HECAM (HEpatocellular CArcinoma Multi-technological consortium grant number and "Association Pour la Recherche sur les Maladies Virales et Hépatiques"(ARMHV). MM, OD, AN and YN are BioPredictive employees. BioPredictive did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries.