FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

NCT02476695 | Completed Results

• 1 other identifier: ChiCTR-DDT-14004429
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 15

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.

Conditions

Liver Fibrosis; Cirrhosis; Chronic Hepatitis B

Keywords

CHB

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (4)

S0/1

S0 = no fibrosis and S1 = portal fibrosis without septa

Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination

S2

S2 = portal fibrosis with few septa

Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination

S3

S3 = numerous septa without cirrhosis

Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination

S4

S4 = liver cirrhosis (compensatory stage)

Device: FibroTouch Examination; Device: FibroScan Examination; Device: Ultrasonic B Examination

Interventions

FibroTouch Examination DEVICE

Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.

S0/1; S2; S3; S4

FibroScan Examination DEVICE

Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.

S0/1; S2; S3; S4

Ultrasonic B Examination DEVICE

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.

S0/1; S2; S3; S4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (15)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

The China-Japan Friendship Hospital

Beijing, China

Location

The Military General Hospital of Beijing, PLA

Beijing, China

Location

The First Bethune Hospital of Jilin University

Changchun, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

The First Affiliated Hospital, Third Military University

Chongqing, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Location

Jiangsu Provincial People's Hospital

Nanjing, China

Location

No.85 Hospital of the PLA

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

The Third Hospital, Hebei Medical University

Shijiazhuang, China

Location

Tianjin Third Central Hospital

Tianjin, China

Location

Hospital of Chinese Medicine of the Xinjiang Uygur Autonomous Region

Ürümqi, China

Location

The First Affiliated Hospital, Fourth Military University

Xi'an, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes

Results Point of Contact

• Title: Peng Lu
• Organization: Wuxi HISKY Medical Technologies Co., Ltd.

yixuebu@fibrotouch.com

13816688340

Study Officials

• Jidong JIA, MD

  Beijing Friendship Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 19, 2015
• Study Start: May 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Locations

CN (15)