FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Research on FibroTouch Noninvasive Evaluation of Liver Fibrosis and Cirrhosis

This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference.

Approximately 600 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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B; Cirrhosis; Liver Fibrosis
• Intervention / Treatment: Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination

Detailed Description

The liver diseases frequently occur in China. For various reasons, the chronic liver diseases are not controlled in time, and then develop gradually into liver fibrosis and cirrhosis. Without effective treatment, the advanced liver cirrhosis seriously influences the quality of patients' life, and places an intolerable burden on family and society. At present, the scholars generally thought that the liver fibrosis at early stages is reversible. Therefore, if the liver fibrosis in patients with chronic liver diseases can be accurately evaluated at early stages and be treated in time, so we can stop the progress of diseases and reduce the occurrence of liver cirrhosis and liver cancer.

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.

Approximately 600 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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Jidong JIA, MD; Email: jia_jd@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: Jidong JIA, MD
  • Beijing, China
    • Recruiting
    • The China-Japan Friendship Hospital
    • Contact: Anlin MA, MD
  • Beijing, China
    • Recruiting
    • The Military General Hospital of Beijing, PLA
    • Contact: Jianbiao CAO, MD
  • Changchun, China
    • Recruiting
    • The First Bethune Hospital of Jilin University
    • Contact: Junqi NIU, MD
  • Chengdu, China
    • Recruiting
    • West China Hospital, Sichuan University
    • Contact: Hong TANG, MD
  • Chongqing, China
    • Recruiting
    • The First Affiliated Hospital, Third Military University
    • Contact: Qing MAO, MD
  • Guangzhou, China
    • Recruiting
    • The Third Affiliated Hospital of Sun Yat-sen University
    • Contact: Zhiliang GAO, MD
  • Nanjing, China
    • Recruiting
    • Jiangsu Provincial People's Hospital
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
  • Shanghai, China
    • Recruiting
    • No.85 Hospital of the PLA
  • Shijiazhuang, China
    • Recruiting
    • The Third Hospital, Hebei Medical University
    • Contact: Yuemin NAN, MD
  • Tianjin, China
    • Recruiting
    • Tianjin Third Central Hospital
    • Contact: Tao HAN, MD
  • Urumqi, China
    • Recruiting
    • Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region
    • Contact: Xiaozhong WANG, MD
  • Xi'an, China
    • Recruiting
    • The First Affiliated Hospital, Fourth Military University
    • Contact: Ying HAN, MD
  • Zhengzhou, China
    • Recruiting
    • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects with chronic hepatitis B (CHB), who underwent a liver biopsy in hospital and meets all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within three months of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for analysis and comparison.

Description

Inclusion Criteria:

• Subjects with age 18-65 years, both gender
• 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 are unable or unwilling to sign informed consent form
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
S0/1; S0 = no fibrosis and S1 = portal fibrosis without septa	Device: FibroTouch Examination; Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.; Device: FibroScan Examination; Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.; Device: 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	Device: FibroTouch Examination; Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.; Device: FibroScan Examination; Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.; Device: 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	Device: FibroTouch Examination; Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.; Device: FibroScan Examination; Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.; Device: 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)	Device: FibroTouch Examination; Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.; Device: FibroScan Examination; Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The coincidence for diagnosis of liver fibrosis and cirrhosis between liver stiffness measurement (LSM) of FibroTouch and liver biopsy by ROC analysis	Performance of liver stiffness measurement (LSM, kPa) of FibroTouch for the non-invasive and quantitative diagnosis of liver fibrosis and cirrhosis in CHB patients with stage S0 (no fibrosis), S1 (portal fibrosis without septa), S2 (portal fibrosis with few septa), S3 (numerous septa without cirrhosis) and S4 (compensatory stage of cirrhosis) will be assessed using ROC analysis, liver biopsy as the reference.	Participants will be offered a FibroTouch examination before or after taking the test of liver biopsy, and the time interval should not exceed 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The coincidence for diagnosis of liver fibrosis and cirrhosis between liver stiffness measurement (LSM) of FibroTouch and FibroScan by ROC analysis	Performance of liver stiffness measurement (LSM, kPa) of FibroTouch and FibroScan for the non-invasive and quantitative diagnosis of liver fibrosis and cirrhosis in CHB patients will be compared using ROC analysis.	Participants will be offered a FibroScan examination at the same time of FibroTouch examination.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between liver stiffness measurement (LSM) of FibroTouch and Ultrasonic examination for diagnosis of liver fibrosis and cirrhosis by ROC analysis	Performance of liver stiffness measurement (LSM, kPa) of FibroTouch and Ultrasonic examination for the non-invasive and quantitative diagnosis of liver fibrosis and cirrhosis in CHB patients will be compared using ROC analysis.	Participants will be offered an Ultrasonic examination at the same time of FibroTouch examination.

Collaborators and Investigators

• Sponsor: Wuxi Hisky Medical Technology Co Ltd
• Collaborators: Beijing Friendship Hospital; West China Hospital; Ruijin Hospital; The First Hospital of Jilin University; Henan Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Tianjin Third Central Hospital; Hebei Medical University Third Hospital; The First Affiliated Hospital of the Fourth Military Medical University; Jiangsu Provincial People's Hospital; The Military General Hospital of Beijing, PLA; The First Affiliated Hospital, Third Military University; No.85 Hospital, Changning, Shanghai, China; Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region; The China-Japan Friendship Hospital; Peking University Clinical Research Institute (PUCRI)
• Investigators: Study Chair: Jidong JIA, MD, Beijing Friendship Hospital; Principal Investigator: Jianbiao CAO, MD, The Military General Hospital of Beijing, PLA; Principal Investigator: Qing MAO, MD, The First Affiliated Hospital, Third Military University; Principal Investigator: Ying HAN, MD, The First Affiliated Hospital of the Fourth Military Medical University; Principal Investigator: Junqi NIU, MD, The First Hospital of Jilin University; Principal Investigator: Yuemin NAN, MD, Hebei Medical University Third Hospital; Principal Investigator: JIA SHANG, MD, Henan Provincial People's Hospital; Principal Investigator: Jun LI, MD, Jiangsu Provincial People's Hospital; Principal Investigator: Qing XIE, MD, Ruijin Hospital; Principal Investigator: Hong TANG, MD, West China hospital; Principal Investigator: Tao HAN, MD, Tianjin Third Central Hospital; Principal Investigator: Qingchun FU, MD, No.85 Hospital, Changning, Shanghai, China; Principal Investigator: Zhiliang GAO, MD, Third Affiliated Hospital, Sun Yat-Sen University; Principal Investigator: Xiaozhong WANG, MD, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region; Principal Investigator: Anlin MA, MD, The China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: May 25, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: CHB
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Fibrosis; Hepatitis B; Hepatitis B, Chronic; Liver Cirrhosis
• Other Study ID Numbers: ChiCTR-DDT-14004429