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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHAPE

    Diagnostic test

    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.

Treatment groups

380 Participants
are divided into 1 treatment group
Group A: SHAPEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HV-PV (dB)

The difference in the average harmonic signal between the hepatic vein and the portal vein

Time frame
Within two weeks of admission
2

Measurement of liver stiffness(kPa)

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.

Time frame
Within two weeks of admission
3

blood platelet count(×10⁹/L)

The peripheral blood of the patient was tested by a conventional blood analyzer to obtain the platelet count.

Time frame
Within two weeks of admission
4

sensitivity and specificity

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).

Time frame
The one-year period from enrollment to the end of the group

Secondary outcomes

Other outcomes

Sponsors and contacts

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