Spleen Stiffness Measurement With FibroScan
关键词
抽象
日期
| 最后验证: | 09/30/2018 |
| 首次提交: | 06/30/2014 |
| 提交的预估入学人数: | 06/30/2014 |
| 首次发布: | 07/01/2014 |
| 上次提交的更新: | 10/08/2018 |
| 最近更新发布: | 10/09/2018 |
| 实际学习开始日期: | 02/29/2012 |
| 预计主要完成日期: | 12/31/2016 |
| 预计完成日期: | 05/31/2017 |
状况或疾病
干预/治疗
Device: Fibroscan®
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: Fibroscan® Fibroscan® is an active non implantable medical device using ultrasound. It has been designed to measure liver stiffness in a painless, rapid and non invasive manner. It is a diagnostic aid tool. In this study, Spleen Stiffness Measurement will be assessed using a dedicated FibroScan® device which has been developed specifically to assess spleen stiffness. | Device: Fibroscan® Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - All groups - Both gender, 18-79 years old - Patient able to give written informed consent form - Patient affiliated to a social security system. - Case group - Patient with chronic liver disease due to: hepatitis C virus, hepatitis B virus or Alcoholic Liver Disease and liver stiffness ≥ 14 kPa - Patient with the following examination within 3 months of LSM and SSM: ultrasound examination, blood examination, gastroscopy examination and eventually an hepatic venous pressure gradient examination - Control groups - Patient with chronic liver disease due to: HCV, HBV or Alcoholic Liver Disease and liver stiffness < 14 kPa - Patients without chronic liver disease (Healthy Control subgroup) Exclusion Criteria: - Patient unable or unwilling to provide written informed consent. - Consuming illness (HIV infection, malignancy). - Associated comorbidities: NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis. - Antiviral treatment during the two months before inclusion. - Pacemaker or heart defibrillator. - Pregnancy. - Liver transplantation. - BMI>35 kg/m2. - Serum Transaminases > 250 IU/L. - History of / or current βblockers treatment of OV. - Presence of ascites. - Previous endoscopic treatment of OV. - Patient with acute alcoholic hepatitis and associated jaundice (generally defined by total bilirubin ≥ 50 µmol/l). - Patient with hepatocellular carcinoma (HCC). - Unable or unwilling to undergo a liver stiffness measurement, a spleen stiffness measurement, an ultrasound examination, a blood examination or a gastroscopy examination. |
结果
主要结果指标
1. Selection of patient with cirrhosis using LSM ≥ 14 kPa (kilopascal) [Up to 36 month]
次要成果指标
1. Diagnosis of large OV with an sensitivity of 95% and an acceptable lower bound of 85% [Up to 36 month]
其他成果措施
1. Prevalence of patients with large OV in cirrhotic patients: 30% [Up to 36 month]
