Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values)
研究概览
简要总结
Abstract:
Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications.
Number of subjects required:
According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital.
Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month.
Methodology:
It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier.
The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests.
Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests.
Primary endpoint :
To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity.
The secondary endpoints were:
Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal
详细描述
Main objective :
The main objective of the study was to determine in patients with morbid obesity waiting for bariatric surgery, the accuracy of non-invasive tests for diagnosis of severe steatosis and / or NASH.
The gold standard is liver biopsy with a morphometric study.
Non-invasive tests will be used:
- Serum tests: the FibroMax (which includes the NASH test, FibroTest and SteatoTest) and FibroMeter.
- Radiological examinations: MRI and FibroScan / CAP
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •BMI ≥ 35 kg/m2
- •Bariatric surgery scheduled within 3 months following the inclusion
- •Conducting a medical examination.
- •Signature of informed consent
排除标准
- •Patient non-affiliated to a social security scheme (beneficiary or assignee)
- •Cons-indication for performing an MRI
- •weight> 230 kg , anteroposterior diameter>40 cm
- •Cancer treatment or medication that may induce lesions of steatohepatitis (corticoids, methotrexate, amiodarone, perhexiline, tamoxifen, nifedipine, diltiazem, hycanthone)
- •Alcohol consumption > 20 g per day for women and > 30 g per day for men AND no past history of excessive alcohol use for more than a 2-year period within the last 20 years
- •known chronic liver disease other than steatosis (presence of HBs antigen, or antibody to HCV, or anti-nuclear antibodies, anti-mitochondria, anti-LKM1, anti-smooth muscle negative, or the presence of a hemochromatosis),
- •known HIV positive status
- •Pregnant women (known pregnancy) or lactating
结局指标
主要结局
To validate the use of serum tests, FibroScan / CAP abdominal MRI for the diagnosis of severe steatosis and / or NASH (specificity, sensitivity, positive and negative predictive values)
时间窗: 3 months
serum tests, FibroScan/CAP abdominal MRI
次要结局
- Histological lesions of liver fibrosis and quantification of abdominal fat by MRI(3 months)