单位：[1]Liver Research Center, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing, China临床科室国家中心肝病分中心首都医科大学附属北京友谊医院[2]Department of Hepatology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China[3]Department of Infectious Diseases, China-Japan Friendship Hospital, Beijing, China[4]Department of Infectious Diseases, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, Henan Province, China[5]Department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China[6]Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China中山大学附属第三医院[7]Center of Infectious Diseases, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China四川大学华西医院[8]Shanghai Liver Diseases Research Center, 85th Hospital, Nanjing Military Command, Shanghai, China[9]Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[10]Department of Infectious Diseases, First Affiliated Hospital of the Army Medical University, Chongqing, China[11]Department of Hepatology, First Hospital of Jilin University, Changchun, Jilin Province, China[12]Tianjin Key Laboratory of Artificial Cells, Artificial Cell Engineering Technology Research Center of Public Health Ministry, Tianjin Third Central Hospital, Tianjin,China[13]Department of Infectious Diseases, First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu Province, China江苏省人民医院[14]Department of Gastroenterology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China[15]Center of Liver Diseases, General Hospital of Beijing Military Region, Beijing, China[16]Clinical Epidemiology and Evidence-Based Medical Center, National Clinical Research Center for Digestive Disease, Beijing Friendship Hospital, Capital Medical University, Beijing, China医技科室北京市临床医学研究所国家消化中心（方法学平台）首都医科大学附属北京友谊医院[17]Department of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China医技科室病理科病理科首都医科大学附属北京友谊医院[18]Department of Pathology, Beijing Youan Hospital, Capital Medical University, Beijing, China[19]Department of Pathology, China-Japan Friendship Hospital, Beijing, China
Objectives To validate the operational and diagnostic performances of a new device for transient elastography (TE), FibroTouch, for liver fibrosis in patients with chronic hepatitis B (CHB). Methods In this prospective multicenter study, adult patients with CHB and valid liver pathological results were recruited to validate the operational and diagnostic performance of a TE device by FibroTouch for staging liver fibrosis. Results In total, 517 patients with histologically proven CHB were enrolled. All had achieved at least 10 successful liver stiffness measurements (LSM), resulting in a success rate of 99.1% and reliable evaluations of 95.2%. Altogether 412 patients were included to analyze the diagnostic performance of FibroTouch. The area under the receiver operating characteristic curve for the LSM was 0.846 (95% confidence interval [CI] 0.808-0.880) for fibrosis stage >= F1, 0.850 (95% CI 0.811-0.883) for >= F2, 0.908 (95% CI 0.876-0.934) for >= F3 and 0.874 (95% CI 0.836-0.903) for F4. The diagnostic accuracy of LSM was superior to that of gamma-glutamyl transpeptidase-to-platelet ratio (GPR), aminotransferase-to-platelet ratio index (APRI), or fibrosis index based on 4 factors (FIB-4) index in staging fibrosis F2-F4 (P= 0.007 to < 0.0001). Optimal LSM cut-off values for diagnosing fibrosis stage >= F1, >= F2, >= F3, and F4 were 5.5 kPa, 7.85 kPa, 10.0 kPa, and 12.7 kPa, respectively. Conclusion FibroTouch has a high success rate and good reliability in staging liver fibrosis in patients with CHB.
基金：
This study was funded by Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, Jiangsu Province, China). Funding Source: Medline
第一作者单位：[1]Liver Research Center, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing, China
通讯作者：
通讯机构：[1]Liver Research Center, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Beijing, China[*1]Liver Research Center, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosi, National Clinical Research Center of Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong'an Road, Xicheng District, Beijing 100050, China
推荐引用方式(GB/T 7714)：
Duan Weijia,Wang Xiaozhong,Ma Anlin,et al.Multicenter prospective study to validate a new transient elastography device for staging liver fibrosis in patients with chronic hepatitis B[J].JOURNAL of DIGESTIVE DISEASES.2020,21(9):519-525.doi:10.1111/1751-2980.12924.
APA：
Duan Weijia,Wang Xiaozhong,Ma Anlin,Shang Jia,Nan Yuemin...&Jia Jidong.(2020).Multicenter prospective study to validate a new transient elastography device for staging liver fibrosis in patients with chronic hepatitis B.JOURNAL of DIGESTIVE DISEASES,21,(9)
MLA：
Duan Weijia,et al."Multicenter prospective study to validate a new transient elastography device for staging liver fibrosis in patients with chronic hepatitis B".JOURNAL of DIGESTIVE DISEASES 21..9(2020):519-525
