Liver FibrosisNCT02476695
FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
An observational study of Liver Fibrosis and Cirrhosis, run by Wuxi Hisky Medical Technology Co Ltd at 15 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Fibrosis, Cirrhosis, Chronic Hepatitis B
- What is being tested?
- FibroTouch Examination, FibroScan Examination and Ultrasonic B Examination
- Type of treatment
- Medical device
- How many people
- 412 participants
- Where
- 15 sitesChina
- Study dates
- May 2014to Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
The China-Japan Friendship Hospital
Beijing
The Military General Hospital of Beijing, PLA
Beijing
The First Bethune Hospital of Jilin University
Changchun
West China Hospital, Sichuan University
Chengdu
The First Affiliated Hospital, Third Military University
Chongqing
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou
Jiangsu Provincial People's Hospital
Nanjing
No.85 Hospital of the PLA
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
The Third Hospital, Hebei Medical University
Shijiazhuang
Tianjin Third Central Hospital
Tianjin
Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region
Ürümqi
The First Affiliated Hospital, Fourth Military University
Xi'an
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Liver Fibrosis, Cirrhosis, Chronic Hepatitis B
- Being tested
- FibroTouch Examination, FibroScan Examination, Ultrasonic B Examination
- Keywords
- CHB
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroTouch ExaminationDevice
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
FibroScan ExaminationDevice
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
Ultrasonic B ExaminationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| S0/1 | S0 = no fibrosis and S1 = portal fibrosis without septa Receives: Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination | |
| S2 | S2 = portal fibrosis with few septa Receives: Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination | |
| S3 | S3 = numerous septa without cirrhosis Receives: Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination | |
| S4 | S4 = liver cirrhosis (compensatory stage) Receives: Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuxi Hisky Medical Technology Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital, The Military General Hospital of Beijing, PLA, The First Affiliated Hospital, Third Military University, The First Affiliated Hospital of the Fourth Military Medical University, The First Hospital of Jilin University, Hebei Medical University Third Hospital, Henan Provincial People's Hospital, Jiangsu Provincial People's Hospital, Ruijin Hospital, West China Hospital, Tianjin Third Central Hospital, No.85 Hospital, Changning, Shanghai, China, Third Affiliated Hospital, Sun Yat-Sen University, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region, China-Japan Friendship Hospital, Peking University Clinical Research Institute (PUCRI)
- Responsible party
- Sponsor
- Investigators
- Jidong JIA, MD, Study chair, Beijing Friendship HospitalJianbiao CAO, MD, Principal investigator, The Military General Hospital of Beijing, PLAQing MAO, MD, Principal investigator, The First Affiliated Hospital, Third Military UniversityYing HAN, MD, Principal investigator, The First Affiliated Hospital of the Fourth Military Medical UniversityJunqi NIU, MD, Principal investigator, The First Hospital of Jilin UniversityYuemin NAN, MD, Principal investigator, Hebei Medical University Third HospitalJIA SHANG, MD, Principal investigator, Henan Provincial People's HospitalJun LI, MD, Principal investigator, Jiangsu Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476695
- Sponsor's protocol ID
- ChiCTR-DDT-14004429
- Status last verified
- Feb 2025
- First submitted
- 25 May 2015
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on FibroTouch Noninvasive Evaluation of Liver Fibrosis and Cirrhosis
- ClinicalTrials.gov ID
- NCT02476695
- Acronym / sponsor ID
- ChiCTR-DDT-14004429
- Conditions
- Liver Fibrosis, Cirrhosis, Chronic Hepatitis B
- Keywords
- CHB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Wuxi Hisky Medical Technology Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital, The Military General Hospital of Beijing, PLA, The First Affiliated Hospital, Third Military University, The First Affiliated Hospital of the Fourth Military Medical University, The First Hospital of Jilin University, Hebei Medical University Third Hospital, Henan Provincial People's Hospital, Jiangsu Provincial People's Hospital, Ruijin Hospital, West China Hospital, Tianjin Third Central Hospital, No.85 Hospital, Changning, Shanghai, China, Third Affiliated Hospital, Sun Yat-Sen University, Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region, China-Japan Friendship Hospital, Peking University Clinical Research Institute (PUCRI)
- Study start
- May 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S0/1 | – | Device: FibroTouch Examination, Device: FibroScan Examination, Device: Ultrasonic B ExaminationS0 = no fibrosis and S1 = portal fibrosis without septa |
| S2 | – | Device: FibroTouch Examination, Device: FibroScan Examination, Device: Ultrasonic B ExaminationS2 = portal fibrosis with few septa |
| S3 | – | Device: FibroTouch Examination, Device: FibroScan Examination, Device: Ultrasonic B ExaminationS3 = numerous septa without cirrhosis |
| S4 | – | Device: FibroTouch Examination, Device: FibroScan Examination, Device: Ultrasonic B ExaminationS4 = liver cirrhosis (compensatory stage) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroTouch ExaminationLiver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless. | Device | S0/1, S2, S3, S4 |
| FibroScan ExaminationLiver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless. | Device | S0/1, S2, S3, S4 |
| Ultrasonic B ExaminationThe 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. | Device | S0/1, S2, S3, S4 |
Primary outcome
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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jidong JIA, MD study chair
Beijing Friendship Hospital
Jianbiao CAO, MD principal investigator
The Military General Hospital of Beijing, PLA
Qing MAO, MD principal investigator
The First Affiliated Hospital, Third Military University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Cirrhosis, run by Wuxi Hisky Medical Technology Co Ltd at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.