FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
NCT ID: NCT02476695
Last Updated: 2025-03-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
412 participants
OBSERVATIONAL
2014-05-31
2018-07-31
Brief Summary
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Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
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Detailed Description
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For many years, liver biopsy is still as "golden standard" for diagnosis of liver inflammation and fibrosis. However, with its invasiveness, potential risks and some complications, liver biopsy is limited in clinical application due to the poor acceptability and repeatability. In recent years, the liver fibrosis cannot directly and accurately diagnose via the various diagnostic models using serological biomarkers (e.g. FIBROTEST and APRI) and medical imaging technologies (e.g. ultrasonic B, CT and MRI).
Transient elastography is a new technology in the field of ultrasonic imaging. Liver stiffness measurement (LSM) is based on the relationship between the speed of spread of acoustic wave in tissues and stiffness of the tissues. It utilizes specific probes to send out controlled low-frequency shear waves, the waves signals transmit through liver tissues, a high-frequency signals will track the transmitting process of shear wave in the liver and the value of liver stiffness (kPa) is quickly calculated with reference to a built-in liver histological model, which provides a quantitative standard for diagnosis of liver fibrosis of chronic liver disease. The bigger LSM value means the faster transmission of shear wave, and the harder of determined liver tissue.
As stated in the "12th Five-year Plan for Medical Device Technological Industry" (the Ministry of Science and Technology), China will greatly support the research and development of new medical devices and promote the application of Chinese transient elastography system, FibroTouch, which was R\&D by Tsing-Hua University independently with new algorithm. FibroTouch can rapidly determine the LSM in a non-invasive way and provide useful information for liver fibrosis and steatosis staging.
Due to FibroTouch is a new transient elastography system in marketing, there is no too much studies on the correlation between FibroTouch and liver biopsy in diagnosis of liver fibrosis and cirrhosis.
The goal of this prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of FibroTouch for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference.
Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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S0/1
S0 = no fibrosis and S1 = portal fibrosis without septa
FibroTouch Examination
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan Examination
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B Examination
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
S2
S2 = portal fibrosis with few septa
FibroTouch Examination
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan Examination
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B Examination
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
S3
S3 = numerous septa without cirrhosis
FibroTouch Examination
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan Examination
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B Examination
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
S4
S4 = liver cirrhosis (compensatory stage)
FibroTouch Examination
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan Examination
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B Examination
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
Interventions
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FibroTouch Examination
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan Examination
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B Examination
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
Eligibility Criteria
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Inclusion Criteria
* Subjects with history of HBV or HBsAg positive \> 6 months up to enrollment
* Subjects with qualified liver biopsy specimens within three months (before or after) of Fibrotouch examination for pathological staging
* Subjects without chemical therapy history of powerful medicine to lower enzyme in the two weeks before blood biochemistry tests (e.g. dimethyl diphenyl bicarboxylate and bicyclol)
* Subjects must agree and sign the informed consent form
Exclusion Criteria
* Subjects who have merger of hepatitis C, alcohol and non-alcoholic fatty liver diseases, autoimmune liver diseases, inherited metabolic liver diseases, biliary systemic diseases or liver and gall parasitic diseases
* Subjects who have other serious chronic disorders or history of malignancy
* Subjects with ALT ≥5 ULN in the past 1 month
* Subjects with WBC\<3.5×10\^9/L, PLT\<60×10\^9/L, PTA\<60%
* Subjects with DBIL≥1.5 ULN
* Subjects with decompensated cirrhosis (especially the people with ascites)
* Pregnant or lactating women, or women who has a pregnant plan and don't want to birth control in the study period
* Subjects who have wound on the right upper abdomen recently
* Subjects who have various space-occupying tumor or cyst in right liver
* Subjects who have none or limited legal capacity
18 Years
65 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
The Military General Hospital of Beijing, PLA
UNKNOWN
The First Affiliated Hospital, Third Military University
UNKNOWN
The First Affiliated Hospital of the Fourth Military Medical University
OTHER
The First Hospital of Jilin University
OTHER
Hebei Medical University Third Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Jiangsu Provincial People's Hospital
OTHER
Ruijin Hospital
OTHER
West China Hospital
OTHER
Tianjin Third Central Hospital
OTHER
No.85 Hospital, Changning, Shanghai, China
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region
UNKNOWN
The China-Japan Friendship Hospital
UNKNOWN
Peking University Clinical Research Institute (PUCRI)
UNKNOWN
Wuxi Hisky Medical Technology Co Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Jidong JIA, MD
Role: STUDY_CHAIR
Beijing Friendship Hospital
Jianbiao CAO, MD
Role: PRINCIPAL_INVESTIGATOR
The Military General Hospital of Beijing, PLA
Qing MAO, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Third Military University
Ying HAN, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of the Fourth Military Medical University
Junqi NIU, MD
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Yuemin NAN, MD
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Third Hospital
JIA SHANG, MD
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Jun LI, MD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial People's Hospital
Qing XIE, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Hong TANG, MD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Tao HAN, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Third Central Hospital
Qingchun FU, MD
Role: PRINCIPAL_INVESTIGATOR
No.85 Hospital, Changning, Shanghai, China
Zhiliang GAO, MD
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Xiaozhong WANG, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region
Anlin MA, MD
Role: PRINCIPAL_INVESTIGATOR
The China-Japan Friendship Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, , China
The China-Japan Friendship Hospital
Beijing, , China
The Military General Hospital of Beijing, PLA
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital, Third Military University
Chongqing, , China
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, , China
Jiangsu Provincial People's Hospital
Nanjing, , China
No.85 Hospital of the PLA
Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
The Third Hospital, Hebei Medical University
Shijiazhuang, , China
Tianjin Third Central Hospital
Tianjin, , China
Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region
Ürümqi, , China
The First Affiliated Hospital, Fourth Military University
Xi'an, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ChiCTR-DDT-14004429
Identifier Type: -
Identifier Source: org_study_id
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