Clinical trial NCT02456766: Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis
Official title: A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fatty Liver
Hepatic Steatosis
Liver Steatosis
Keywords: FibroTouch
acoustic attenuation parameter
liver biopsy
hepatic steatosis
Lead sponsor: Wuxi Hisky Medical Technology Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Guangzhou First People's Hospital
name: Ruijin Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: No.85 Hospital, Changning, Shanghai, China
name: The Second Hospital of Nanjing Medical University
name: Sichuan Academy of Medical Sciences
name: Second People's Hospital of Hangzhou
First posted: 2015-05-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
timeFrame: Within two weeks of FibroTouch examination
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Hangzhou
country: China
facility: Second People's Hospital of Hangzhou
city: Nanjing
country: China
facility: The Second Hospital Of Nanjing
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai 85 Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Lungen LU, MD
role: STUDY_CHAIR
References:
citation: 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.