Gastroenterology

Gastroenterology

Volume 156, Issue 6, May 2019, Pages 1717-1730
Gastroenterology

Original Research
Full Report: Clinical—Liver
Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease

https://doi.org/10.1053/j.gastro.2019.01.042Get rights and content

Background & Aims

We estimated the accuracy of FibroScan vibration-controlled transient elastography controlled attenuation parameter (CAP) and liver stiffness measurement (LSMs) in assessing steatosis and fibrosis in patients with suspected nonalcoholic liver disease (NAFLD).

Methods

We collected data from 450 consecutive adults who underwent liver biopsy analysis for suspected NAFLD at 7 centers in the United Kingdom from March 2014 through January 2017. FibroScan examinations with M or XL probe were completed within the 2 weeks of the biopsy analysis (404 had a valid examination). The biopsies were scored by 2 blinded expert pathologists according to nonalcoholic steatohepatitis clinical research network criteria. Diagnostic accuracy was estimated using the area under the receiver operating characteristic curves (AUROCs) for the categories of steatosis and fibrosis. We assessed effects of disease prevalence on positive and negative predictive values. For LSM, the effects of histological parameters and probe type were appraised using multivariable analysis.

Results

Using biopsy analysis as the reference standard, we found that CAP identified patients with steatosis with an AUROC of 0.87 (95% confidence interval [CI] 0.82–0.92) for S≥S1, 0.77 (95% CI 0.71–0.82) for S≥S2, and 0.70 (95% CI 0.64–0.75) for S=S3. Youden cutoff values for S≥S1, S≥S2, and S≥S3 were 302 dB/m, 331 dB/m, and 337 dB/m, respectively. LSM identified patients with fibrosis with AUROCs of 0.77 (95% CI 0.72–0.82) for F≥F2, 0.80 (95% CI 0.75–0.84) for F≥F3, and 0.89 (95% CI 0.84–0.93) for F=F4. Youden cutoff values for F≥F2, F≥F3, and F=F4 were 8.2 kPa, 9.7 kPa, and 13.6 kPa, respectively. Applying the optimal cutoff values, determined from this cohort, to populations of lower fibrosis prevalence increased negative predictive values and reduced positive predictive values. Multivariable analysis found that the only parameter that significantly affected LSMs was fibrosis stage (P<10–16); we found no association with steatosis or probe type.

Conclusions

In a prospective analysis of patients with NAFLD, we found CAP and LSM by FibroScan to assess liver steatosis and fibrosis, respectively, with AUROC values ranging from 0.70 to 0.89. Probe type and steatosis did not affect LSM. Study registration: ClinicalTrials.gov Identifier: NCT01985009.

Keywords

VCTE
NASH
Noninvasive
Biomarker

Abbreviations used in this paper

ALT
alanine transaminase
AUC
area under the curve
AUROC
area under the receiver operating characteristic curve
BMI
body mass index
CAP
controlled attenuation parameter
CI
confidence interval
CRN
clinical research network
IQR
interquartile range
LB
liver biopsy
LSM
liver stiffness measurement
NAFL
nonalcoholic fatty liver
NAFLD
nonalcoholic fatty liver disease
NASH
nonalcoholic steatohepatitis
NFS
NAFLD fibrosis score
NPV
negative predictive value
PPV
positive predictive value
Se
sensitivity
STARD
standards for reporting of diagnostic accuracy studies
ULN
upper limit of normal
VCTE
vibration-controlled transient elastography

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Conflicts of interest The authors disclose no conflicts.

Funding This work was funded by Echosens, the sponsors of this study. Peter J. Eddowes, Jon Deeks, and Philip N. Newsome were supported by the National Institute of Health Research (NIHR) Birmingham Biomedical Research Centre (BRC). Jeremy F. Cobbold was supported by the NIHR Oxford BRC. Indra N. Guha was supported by NIHR Nottingham BRC. This study/project is supported by the National Institute for Health Research Birmingham Biomedical Research Centre (Grant Reference Number BRC-1215-20009). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

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