Development and validation of a novel non‐invasive test for diagnosing fibrotic non‐alcoholic steatohepatitis in patients with biopsy‐proven non‐alcoholic fatty liver disease
Background and Aim There is an immediate need for non‐invasive accurate tests for diagnosing liver fibrosis in patients with non‐alcoholic steatohepatitis (NASH). Previously, it has been suggested that MACK‐3 (a formula that combines homeostasis model assessment‐insulin resistance with serum serum a...
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Published in | Journal of gastroenterology and hepatology Vol. 35; no. 10; pp. 1804 - 1812 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Australia
Wiley Subscription Services, Inc
01.10.2020
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Subjects | |
Online Access | Get full text |
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Summary: | Background and Aim
There is an immediate need for non‐invasive accurate tests for diagnosing liver fibrosis in patients with non‐alcoholic steatohepatitis (NASH). Previously, it has been suggested that MACK‐3 (a formula that combines homeostasis model assessment‐insulin resistance with serum serum aspartate aminotransferase and cytokeratin [CK]18‐M30 levels) accurately identifies patients with fibrotic NASH. Our aim was to assess the performance of MACK‐3 and develop a novel, non‐invasive algorithm for diagnosing fibrotic NASH.
Methods
Six hundred and thirty‐six adults with biopsy‐proven non‐alcoholic fatty liver disease (NAFLD) from two independent Asian cohorts were enrolled in our study. Liver stiffness measurement (LSM) was assessed by vibration‐controlled transient elastography (Fibroscan). Fibrotic NASH was defined as NASH with a NAFLD activity score (NAS) ≥ 4 and F ≥ 2 fibrosis.
Results
Metabolic syndrome (MetS), platelet count and MACK‐3 were independent predictors of fibrotic NASH. On the basis of their regression coefficients, we developed a novel nomogram showing a good discriminatory ability (area under receiver operating characteristic curve [AUROC]: 0.79, 95% confidence interval [CI 0.75–0.83]) and a high negative predictive value (NPV: 94.7%) to rule out fibrotic NASH. In the validation set, this nomogram had a higher AUROC (0.81, 95%CI 0.74–0.87) than that of MACK‐3 (AUROC: 0.75, 95%CI 0.68–0.82; P < 0.05) with a NPV of 93.2%. The sequential combination of this nomogram with LSM data avoided the need for liver biopsy in 56.9% of patients.
Conclusions
Our novel nomogram (combining MACK‐3, platelet count and MetS) shows promising utility for diagnosing fibrotic NASH. The sequential combination of this nomogram and vibration‐controlled transient elastography limits indeterminate results and reduces the number of unnecessary liver biopsies. |
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Bibliography: | Ethical approval Feng Gao and Ming‐Hua Zheng carried out the study concept and design. Wah‐Kheong Chan, Hong‐Lei Ma, Xiao‐Yan Pan and Wen‐Yue Liu were responsible for the acquisition of data. Yang‐Yang Li did the pathology analysis. Feng Gao and Kenneth I. Zheng drafted the manuscript. Giovanni Targher, Christopher D. Byrne and Wah‐Kheong Chan did the critical revision. Feng Gao and Jiao‐Feng Huang contributed to the statistical analysis. Yong‐Ping Chen and Ming‐Hua Zheng carried out the study supervision. All authors contributed to the manuscript for important intellectual content and approved the submission. Ethical approval for the study was obtained from the ethics committee of the First Affiliated Hospital of Wenzhou Medical University and University of Malaya. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Author contributions ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 0815-9319 1440-1746 |
DOI: | 10.1111/jgh.15055 |