The Diagnostic Value of Subharmonic Imaging Technology Combined With Liver Stiffness and Platelet Count for High-risk Esophageal and Gastric Varices in Patients With Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- HV-PV (dB)
研究概览
简要总结
To evaluate the diagnostic value of the combined model of subharmonic-assisted pressure estimation (SHAPE), liver stiffness (LSM), and platelet count (PLT) for high-risk esophageal and gastric varices (HRV)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The SHAPE operator and the analyst, the LSM operator, and the gastroscopy operator blinded each other (unaware of each other's results and clinical data), and the SHAPE images were independently analyzed by two ultrasound physicians.
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
- •① Be at least 18 years old② Clinically diagnosed as liver cirrhosis (based on medical history, physical signs, laboratory tests, imaging or liver biopsy)③ Underwent a gastroscopy④ The informed consent form has been signed
排除标准
- •① Previous EV bleeding or having received TIPS/ endoscopic treatment.② History of concurrent liver cancer, portal vein thrombosis, and splenectomy.③ Having used drugs that affect platelet count, liver function or coagulation function in the body within one week, and having a recent history of blood product infusion.
研究组 & 干预措施
SHAPE
Use an ultrasound probe to scan the liver to locate the portal vein and hepatic vein. In the angiography mode, the portal vein and hepatic vein of the same depth were selected for measurement respectively. Ultrasound contrast agent was injected through the elbow vein to observe the changes of sub-harmonic signals in the portal vein and hepatic vein. Collect the sub-harmonic signal data of the portal vein and hepatic vein, and calculate the difference between the two, that is, the SHAPE gradient.
干预措施: SHAPE (Diagnostic Test)
结局指标
主要结局
HV-PV (dB)
时间窗: Within two weeks of admission
The difference in the average harmonic signal between the hepatic vein and the portal vein
Measurement of liver stiffness（kPa）
时间窗: Within two weeks of admission
The patient lies on their back, with their right hand placed behind their head. The right upper limb is fully abducted to expose the intercostal Spaces in the right lobe of the liver. The area usually enclosed by the horizontal line of the xiphoid process, the midline of the right axilla and the lower edge of the rib is taken as the testing area. The probe is vertically and closely attached to the skin, and the measurement position is selected in the intercostal space.
blood platelet count（×10⁹／L）
时间窗: Within two weeks of admission
The peripheral blood of the patient was tested by a conventional blood analyzer to obtain the platelet count.
sensitivity and specificity
时间窗: The one-year period from enrollment to the end of the group
The sensitivity measures the ability of the model to correctly identify patients with HRV (i.e., the true positive rate), and the specificity measures the ability of the model to correctly exclude patients without HRV (i.e., the true negative rate).
Positive predictive value (PPV) and negative predictive value (NPV)
时间窗: The one-year period from enrollment to the end of the group
PPV represents the probability that patients identified as high-risk by the model actually have HRV, while NPV represents the probability that patients identified as low-risk by the model do not actually have HRV
AUC
时间窗: The one-year period from enrollment to the end of the group
Comprehensively reflect the overall discriminative ability of the model under different thresholds
次要结局
未报告次要终点
研究者
Dezhi Zhang
Principal Investigator, PI
The First Hospital of Jilin University