Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis

A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis

This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.

The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.

Study Overview

• Status: Unknown
• Conditions: Fatty Liver; Hepatic Steatosis; Liver Steatosis
• Intervention / Treatment: Device: FibroTouch; Procedure: Liver Biopsy

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Recruiting
    • Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
  • Guangzhou, China
    • Recruiting
    • Guangzhou First Municipal People's Hospital
    • Contact: Yongjian ZHOU, MD
  • Hangzhou, China
    • Recruiting
    • Second People's Hospital of Hangzhou
  • Nanjing, China
    • Recruiting
    • The Second Hospital of Nanjing
    • Contact: Yongfeng YANG, MD
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital
  • Shanghai, China
    • Recruiting
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Jiangao Fan, MD
  • Shanghai, China
    • Recruiting
    • Shanghai First People's Hospital
    • Contact: Lungen LU, MD; Email: lungenlu1965@163.com
  • Shanghai, China
    • Recruiting
    • Shanghai 85 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.

Description

Inclusion Criteria:

• Subject at the age of 18 to 65 years, non-limited gender.
• Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
• Willing and able to abide by all principles and complete all study procedures.
• Willing and can provide written informed consent form by patient or patient's legal guardian.

Exclusion Criteria:

• Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
• There is evidence that the subject has a history of alcohol overdoses* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
• Subject with alcoholic liver disease and hepatitis C.
• Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
• Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
• Subject with non-healing wound on the right upper abdomen at this moment.
• In the investigator's opinion, the subject is unsuitable to participate in the study as he or she has a history of serious illness, or other evidence shown that the subject has any other serious illness.
• Subject who participates in other clinical trial at the same time.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
F0; Liver Steatosis Grade: <5%	Device: FibroTouch; Procedure: Liver Biopsy
F1; Liver Steatosis Grade: 5-33%	Device: FibroTouch; Procedure: Liver Biopsy
F2; Liver Steatosis Grade: 34-66%	Device: FibroTouch; Procedure: Liver Biopsy
F3; Liver Steatosis Grade: > 66%	Device: FibroTouch; Procedure: Liver Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis	Performance of fat attenuation parameter (FAP, dB/m) of FibroTouch will be assessed using ROC analysis for the detection of hepatic steatosis stage F0 (<5%), stage F1 (5%-33%), stage F2 (34%-66%), and stage F3 (2>66%) using liver biopsy as the reference.	Within two weeks of FibroTouch examination

Collaborators and Investigators

• Sponsor: Wuxi Hisky Medical Technology Co Ltd
• Collaborators: Guangzhou First People's Hospital; Ruijin Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Second People's Hospital of Hangzhou; Sichuan Academy of Medical Sciences; The Second Hospital of Nanjing Medical University; No.85 Hospital, Changning, Shanghai, China
• Investigators: Study Chair: Lungen LU, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Qu Y, Song YY, Chen CW, Fu QC, Shi JP, Xu Y, Xie Q, Yang YF, Zhou YJ, Li LP, Xu MY, Cai XB, Zhang QD, Yu H, Fan JG, Lu LG. Diagnostic Performance of FibroTouch Ultrasound Attenuation Parameter and Liver Stiffness Measurement in Assessing Hepatic Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Clin Transl Gastroenterol. 2021 Apr 13;12(4):e00323. doi: 10.14309/ctg.0000000000000323.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: March 22, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: liver biopsy; hepatic steatosis; FibroTouch; acoustic attenuation parameter
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: TG1310FT