Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis
NCT ID: NCT02456766
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
240 participants
OBSERVATIONAL
2014-06-30
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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F0
Liver Steatosis Grade: \<5%
FibroTouch
Liver Biopsy
F1
Liver Steatosis Grade: 5-33%
FibroTouch
Liver Biopsy
F2
Liver Steatosis Grade: 34-66%
FibroTouch
Liver Biopsy
F3
Liver Steatosis Grade: \> 66%
FibroTouch
Liver Biopsy
Interventions
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FibroTouch
Liver Biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Guangzhou First People's Hospital
OTHER
Ruijin Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
No.85 Hospital, Changning, Shanghai, China
OTHER
The Second Hospital of Nanjing Medical University
OTHER
Sichuan Academy of Medical Sciences
OTHER
Second People's Hospital of Hangzhou
UNKNOWN
Wuxi Hisky Medical Technology Co Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lungen LU, MD
Role: STUDY_CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital
Chengdu, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
Second People's Hospital of Hangzhou
Hangzhou, , China
The Second Hospital Of Nanjing
Nanjing, , China
Ruijin Hospital
Shanghai, , China
Shanghai 85 Hospital
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Liangping LI, MD
Role: primary
Yongjian ZHOU, MD
Role: primary
Junping SHI, MD
Role: primary
Yongfeng YANG, MD
Role: primary
Qing XIE, MD
Role: primary
Qingchun FU, MD
Role: primary
Jiangao FAN, MD
Role: primary
References
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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.
Other Identifiers
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TG1310FT
Identifier Type: -
Identifier Source: org_study_id
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