FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Completed

Conditions: Chronic Hepatitis B
Liver Fibrosis
Cirrhosis

Interventions: Device: FibroTouch Examination
Device: FibroScan Examination
Device: Ultrasonic B Examination

Registration Number: NCT02476695

Lead Sponsor: Wuxi Hisky Medical Technology Co Ltd

Brief Summary: 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.

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.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 412

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
S3	FibroScan Examination	S3 = numerous septa without cirrhosis
S4	FibroTouch Examination	S4 = liver cirrhosis (compensatory stage)
S3	Ultrasonic B Examination	S3 = numerous septa without cirrhosis
S0/1	Ultrasonic B Examination	S0 = no fibrosis and S1 = portal fibrosis without septa
S2	Ultrasonic B Examination	S2 = portal fibrosis with few septa
S0/1	FibroTouch Examination	S0 = no fibrosis and S1 = portal fibrosis without septa
S2	FibroTouch Examination	S2 = portal fibrosis with few septa
S0/1	FibroScan Examination	S0 = no fibrosis and S1 = portal fibrosis without septa
S2	FibroScan Examination	S2 = portal fibrosis with few septa
S3	FibroTouch Examination	S3 = numerous septa without cirrhosis
S4	FibroScan Examination	S4 = liver cirrhosis (compensatory stage)
S4	Ultrasonic B Examination	S4 = liver cirrhosis (compensatory stage)

Primary Outcome Measures

Name	Time	Method
The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold Standard for Judging CHB Liver Fibrosis Stage	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.	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 for ≥ F2, 0.908 for ≥ F3 and 0.874 for F4. 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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (15): 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
🇨🇳
Urumqi, China
The First Affiliated Hospital, Fourth Military University
🇨🇳
Xi'an, China
Henan Provincial People's Hospital
🇨🇳
Zhengzhou, China