FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

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.

Conditions

• Liver Fibrosis
• Cirrhosis
• Chronic Hepatitis B

Interventions

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.

Sponsors & Collaborators

• Beijing Friendship Hospital

  collaborator OTHER

• The Military General Hospital of Beijing, PLA

  collaborator UNKNOWN

• The First Affiliated Hospital, Third Military University

  collaborator UNKNOWN

• The First Affiliated Hospital of the Fourth Military Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Tianjin Third Central Hospital

  collaborator OTHER

• No.85 Hospital, Changning, Shanghai, China

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region

  collaborator UNKNOWN

• The China-Japan Friendship Hospital

  collaborator UNKNOWN

• Peking University Clinical Research Institute (PUCRI)

  collaborator UNKNOWN

• Wuxi Hisky Medical Technology Co Ltd

  lead INDUSTRY

Principal Investigators

• Jidong JIA, MD · Beijing Friendship Hospital

• Jianbiao CAO, MD · The Military General Hospital of Beijing, PLA

• Qing MAO, MD · The First Affiliated Hospital, Third Military University

• Ying HAN, MD · The First Affiliated Hospital of the Fourth Military Medical University

• Junqi NIU, MD · The First Hospital of Jilin University

• Yuemin NAN, MD · Hebei Medical University Third Hospital

• JIA SHANG, MD · Henan Provincial People's Hospital

• Jun LI, MD · Jiangsu Provincial People's Hospital

• Qing XIE, MD · Ruijin Hospital

• Hong TANG, MD · West China Hospital

• Tao HAN, MD · Tianjin Third Central Hospital

• Qingchun FU, MD · No.85 Hospital, Changning, Shanghai, China

• Zhiliang GAO, MD · Third Affiliated Hospital, Sun Yat-Sen University

• Xiaozhong WANG, MD · Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region

• Anlin MA, MD · The China-Japan Friendship Hospital

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2018-07-31

Completion

2018-07-31

Countries

• China

Study Locations