Retrospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2021; 27(7): 641-653
Published online Feb 21, 2021. doi: 10.3748/wjg.v27.i7.641
Effect of liver inflammation on accuracy of FibroScan device in assessing liver fibrosis stage in patients with chronic hepatitis B virus infection
Ling-Ling Huang, Xue-Ping Yu, Ju-Lan Li, Hui-Ming Lin, Na-Ling Kang, Jia-Ji Jiang, Yue-Yong Zhu, Yu-Rui Liu, Da-Wu Zeng
Ling-Ling Huang, Hui-Ming Lin, Na-Ling Kang, Jia-Ji Jiang, Yue-Yong Zhu, Yu-Rui Liu, Da-Wu Zeng, Department of Hepatology, Hepatology Research Institute, The First Affiliated Hospital, Fujian Medical University, Fuzhou 350005, Fujian Province, China
Xue-Ping Yu, Ju-Lan Li, Department of Infectious Diseases, The First Hospital of Quanzhou Affiliated to Fujian Medical University, Quanzhou 362000, Fujian Province, China
Yue-Yong Zhu, Fujian Key Laboratory of Precision Medicine for Cancer, Fujian Key Laboratory of Laboratory Medicine, The First Affiliated Hospital, Fujian Medical University, Fuzhou 350005, Fujian Province, China
Author contributions: Huang LL, Liu YR, Yu XP, Li JL contributed equally to this work; Huang LL, Zeng DW and Liu YR conceived and designed the experiments; Huang LL, Jiang JJ and Zeng DW performed the experiments; Huang LL, Yu XP, Zeng DW and Zhu YY analyzed the data; Li JL, Lin HM and Kang NL contributed the reagents/materials/analysis tools; Huang LL and Zeng DW wrote the manuscript; all authors approved the final version of the manuscript.
Supported by Science and Technology Department of Fujian Province, China, No. 2019Y0015 and No. 2019J01432; Chinese National 13th Five-Year Plan's Science and Technology Projects, No. 2017ZX10202201; Quanzhou Science and Technology Project of Fujian Province, China, No. 2018Z074.
Institutional review board statement: This study was approved by the Institutional Review Board of Fujian Medical University.
Informed consent statement: The need for informed consent was waived due to the retrospective nature of the study.
Conflict-of-interest statement: We have no financial relationships to disclose.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Da-Wu Zeng, MD, PhD, Associate Chief Physician, Doctor, Department of Hepatology, Hepatology Research Institute, The First Affiliated Hospital, Fujian Medical University, No. 20 Chazhong Road, Taijiang District, Fuzhou 350005, Fujian Province, China. zengdw1980@fjmu.edu.cn
Received: November 26, 2020
Peer-review started: November 26, 2020
First decision: December 21, 2020
Revised: December 30, 2020
Accepted: January 13, 2021
Article in press: January 13, 2021
Published online: February 21, 2021
ARTICLE HIGHLIGHTS
Research background

Transient elastography (FibroScan) is a new and non-invasive test, which can replace biopsy and has been widely recommended by the guidelines of chronic hepatitis B virus (HBV) management for assessing hepatic fibrosis staging. Liver stiffness measurement (LSM) by FibroScan is associated with the degree of hepatic fibrosis, but can also be confounded by liver necroinflammation, alanine aminotransferase (ALT), cholestasis, portal hypertension, hepatic congestion, and body mass index (BMI) and other factors, which may affect the diagnostic accuracy of the FibroScan device in fibrosis staging.

Research motivation

Many studies suggested that the cutoff value of LSM tends to increase with elevated ALT level, and its diagnostic accuracy tends to decrease with elevated ALT level, but it is not clear whether pathological hepatic inflammation would similarly affect LSM values and diagnostic accuracy of FibroScan assessing hepatic fibrosis.

Research objectives

We aimed to evaluate the diagnostic value of FibroScan and the effect of hepatic inflammation on the accuracy of FibroScan assessing liver fibrosis staging in patients with chronic HBV infection, and to develop a predictive model combining other related non-invasive confounders to predict the risk of FibroScan staging misdiagnosis.

Research methods

The data of 416 patients with chronic HBV infection who accepted FibroScan, liver biopsy, clinical, and biological examination were retrospectively collected between January 2014 and December 2019 from two affiliated hospitals of Fujian Medical University. Receiver operating characteristic (ROC) curves were used to analyze the data. The diagnostic performance of FibroScan for the stage of liver fibrosis was analyzed using ROC curves. Any discordance in fibrosis staging by FibroScan and pathological scores was statistically analyzed. The accuracy of FibroScan in assessing the stage of fibrosis in patients with different degrees of liver inflammation was analyzed using Logistic regression and ROC curves. A non-invasive model was constructed to predict the risk of misdiagnosis of fibrosis stage using FibroScan.

Research results

We confirmed that LSM values obtained using FibroScan were positively correlated with hepatic fibrosis and demonstrated the good performance of FibroScan in predicting the stage of liver fibrosis. However, discordance between the fibrosis stage determined using FibroScan and that determined by pathological examination was observed in some patients. Furthermore, we found that liver inflammatory activity over 2 was an independent risk factor for misdiagnosis of fibrosis stage using FibroScan. Patients with liver inflammation activity ≥ 2 showed higher LSM values using FibroScan and higher rates of misdiagnosis of fibrosis stage, whereas the diagnostic performance of FibroScan for different fibrosis stages was significantly lower than that in patients with inflammation activity < 2. A non-invasive prediction model was established to assess the risk of misdiagnosis of fibrosis stage using FibroScan, and the area under the curve was 0.701, which was superior to that observed using other single related factors.

Research conclusions

Liver inflammation was an independent risk factor affecting the diagnostic accuracy of FibroScan for HBV-related fibrosis staging. The combination of other related non-invasive factors can predict the risk of misdiagnosis of fibrosis staging using FibroScan, and may be helpful for making decisions on liver biopsy and guiding the diagnosis and therapy of chronic HBV infection.

Research perspectives

This multi-center cross-sectional study developed and evaluated a noninvasive model to predict the risk of misdiagnosis of fibrosis staging using FibroScan, thus an extensive liver biopsy database should be established to comprehensively evaluate the reliable cut-off value of FibroScan for assessing the stage of liver fibrosis and further verify the diagnostic performance of this model in future prospective studies.