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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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)

Eligibility

Primary outcome measure(s)

• HV-PV (dB) — 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） — 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） — 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 — 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) — 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 — The one-year period from enrollment to the end of the group
  Comprehensively reflect the overall discriminative ability of the model under different thresholds

Trial sites (1)

More The First Hospital of Jilin University trials in China

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