FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Cirrhosis Clinical Trial

Official title:

Research on FibroTouch Noninvasive Evaluation of Liver Fibrosis and Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02476695
• Other study ID #: ChiCTR-DDT-14004429
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2015
• Last updated: June 16, 2015
• Start date: May 2014

Study information

• Verified date: June 2015
• Source: Wuxi Hisky Medical Technology Co Ltd
• Contact: Jidong JIA, MD
• Email: jia_jd[@]ccmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Cirrhosis
• Fibrosis
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (17)

Lead Sponsor

Collaborator

Wuxi Hisky Medical Technology Co Ltd

Beijing Friendship Hospital, Henan Provincial Hospital, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region, Jiangsu Provincial People's Hospital, No.85 Hospital, Changning, Shanghai, China, Peking University Clinical Research Institute (PUCRI), Ruijin Hospital, The China-Japan Friendship Hospital, The First Affiliated Hospital, Fourth Military University, The First Affiliated Hospital, Third Military University, The First Bethune Hospital of Jilin University, The Military General Hospital of Beijing, PLA, The Third Hospital, Hebei Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Tianjin Third Central Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Primary	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.	No
Secondary	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.	No