Accuracy of non-invasive scoring systems for diagnosing non-alcoholic steatohepatitis-related fibrosis: Multicenter validation study

Yoshito Itoh; Yuya Seko; Toshihide Shima; Tomoaki Nakajima; Kei Mizuno; Yusuke Kawamura; Norio Akuta; Kiyoaki Ito; Miwa Kawanaka; Akira Hiramatsu; Michiie Sakamoto; Kenichi Harada; Yoshihito Goto; Takeo Nakayama; Hiromitsu Kumada; Takeshi Okanoue

doi:10.1111/hepr.13226

Accuracy of non-invasive scoring systems for diagnosing non-alcoholic steatohepatitis-related fibrosis: Multicenter validation study

Hepatol Res. 2018 Dec;48(13):1099-1107. doi: 10.1111/hepr.13226. Epub 2018 Aug 6.

Authors

Affiliations

¹ Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
² Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan.
³ Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo, Japan.
⁴ Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan.
⁵ Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
⁶ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Aichi Medical University, Nagakute, Japan.
⁷ Department of General Internal Medicine 2, Kawasaki Medical School General Medical Center, Okayama, Japan.
⁸ Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.
⁹ Department of Pathology, Keio University School of Medicine, Tokyo, Japan.
¹⁰ Department of Human Pathology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
¹¹ Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan.

PMID: 29974624
DOI: 10.1111/hepr.13226

Abstract

Aim: Hepatic fibrosis is the most important factor for estimating the prognosis of patients with non-alcoholic fatty liver disease (NAFLD). A novel non-invasive scoring system, the FM-fibro index, showed high accuracy in a pilot study. The purpose of this study was to validate the efficacy of the FM-fibro index in a multicenter cohort.

Methods: Among 18 institutions, we analyzed 400 Japanese patients with biopsy-proven NAFLD. We evaluated the accuracies of the FM-fibro index, CA-fibro index, and European Liver Fibrosis (ELF) panel by area under the receiver operator characteristics curves (AUROC). The FM-fibro index includes three formulas for type IV collagen 7S, hyaluronic acid, and vascular cell adhesion molecule-1.

Results: Among 400 patients, 205 were women, and the median age was 56 years. The histological distribution of Matteoni types 1, 2, 3, and 4 was 11, 40, 15, and 334, and the distribution of hepatic fibrosis stages 0 to 4 was 67, 183, 55, 63, and 32, respectively. The AUROCs of the FM-fibro index, CA-fibro index, and ELF panel for non-alcoholic steatohepatitis (NASH)-related fibrosis were 0.7178/0.7095/0.7065, 0.7093, and 0.7245, respectively. The sensitivity and specificity of the FM-fibro index for predicting NASH-related fibrosis was 0.5359/0.5210/0.4641 and 0.8333/0.8182/0.8788, respectively. The accuracy of the FM-fibro index was not significantly different from that of the CA-fibro index or the ELF panel.

Conclusions: The FM-fibro index can predict NASH-related fibrosis with sufficient accuracy compared with previous scoring systems. Further analyses that verify the accuracy of the FM-fibro index to distinguish significant or advanced fibrosis in patients with NAFLD are awaited. (UMIN-CTR: UMIN000018158).

Keywords: FM-fibro index; liver fibrosis; non-alcoholic fatty liver disease.