Liver and Spleen Stiffness Measured by 2D-shear Wave Elastography for Diagnosis of Liver Fibrosis in Patients With Compensated Advanced Chronic Liver Disease: a Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Specificity of 2D-SWE
研究概览
简要总结
A observational diagnostic study will be conducted to evaluate the performance of liver stiffness and spleen stiffness measured by 2D-shear wave elastography (2D-SWE) for diagnosing liver fibrosis in people with compensated Advanced Chronic Liver Disease (cACLD), and explore the cut-off value of 2D-SWE for diagnosing liver fibrosis.
详细描述
Patients with chronic liver disease who visit Fifth Affiliated Hospital, Sun Yat-Sen University will be enrolled from October 2023 to January 2025. Their liver stiffness measured by transient elastography (TE) should be at least 10 kilopascal (kPa) and with no previous decompensation symptoms.
Patients will be asked to sign an informed consent form. After that, researchers will assess the eligibility of the participants according to inclusion and exclusion criteria, and record their demographic data, history of disease, and the etiology of liver disease.
The participants will be required to complete relevant laboratory tests such as blood routine, liver function, kidney function, coagulation function and etiology. After completing the tests, the results will be recorded by primary researchers.
Abdominal ultrasound and 2D-shear wave elastography (2D-SWE) will be conducted by a sonographer, the interval between ultrasonic examination and laboratory tests should be less than a week, and the patients should fast for at least 4 hours before the examination. Abdominal ultrasound findings, liver stiffness, spleen stiffness, spleen thickness, spleen diameter, portal vein trunk diameter will be recorded by primary researchers.
TE examination will be conducted by experienced nurses, instructing patients to have a fasting period of at least 4 hours prior to the tests. An interval of no more than 1 week should separate the abdominal ultrasound and 2D-SWE examination. The report will be considered highly reliable only if the interquartile range to median ratio (IQR/med) is ≤ 30%, at least 10 successful acquisitions are obtained, and the success rate is at least 60%. Liver stiffness, spleen stiffness and controlled attenuation parameter (CAP) will be recorded by primary researchers.
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 old;
- •Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
- •No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
- •Informed consent has been signed.
排除标准
- •Hepatocellular carcinoma or other advanced malignant tumor;
- •Acute liver disease or ALT≥5×ULN;
- •Persistent substance abuse other than alcohol;
- •Pregnancy or HIV infection;
- •There are contraindications of percutaneous liver biopsy (such as serious abnormality of coagulation function, etc.);
- •There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI≥30, etc.);
- •Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.
结局指标
主要结局
Specificity of 2D-SWE
时间窗: Through study completion, an average of 2 year
True Negative/ (True Negative+False Positive) ×100%
Sensitivity of 2D-SWE
时间窗: Through study completion, an average of 2 year
True Positive/ (True Positive+False Negative) ×100%
Negative Predictive Value of TE and 2D-SWE
时间窗: Through study completion, an average of 2 year
True Negative/ (True Negative+False Negative) ×100%
Positive Predictive Value of 2D-SWE
时间窗: Through study completion, an average of 2 year
True Positive/ (True Positive+False Positive) ×100%
Overall diagnostic performance of TE and 2D-SWE
时间窗: Through study completion, an average of 2 year
Measured by the area under the receiver operating characteristic curve (AUROC). The test accuracy level is considered high when the AUROC value is ≥ 0.9.
次要结局
未报告次要终点