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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
Author(s) -
Gao Feng,
Huang JiaoFeng,
Zheng Kenneth I.,
Pan XiaoYan,
Ma HongLei,
Liu WenYue,
Byrne Christopher D.,
Targher Giovanni,
Li YangYang,
Chen YongPing,
Chan WahKheong,
Zheng MingHua
Publication year - 2020
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.15055
Subject(s) - medicine , steatohepatitis , fatty liver , liver biopsy , transient elastography , nomogram , gastroenterology , metabolic syndrome , receiver operating characteristic , confidence interval , fibrosis , biopsy , disease , obesity
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.