A Multicenter Clinical Study on the Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for the Diagnosis of Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The coincidence for diagnosis of hepatic steatosis between fat attenuation parameter (FAP) of FibroTouch and liver biopsy by ROC analysis
时间窗: Within two weeks of FibroTouch examination
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.
次要结局
未报告次要终点