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NCT Number: NCT07151885

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location status: Recruiting

Location contact

dezhi zhang

CONTACT

[email protected]

MD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. HV-PV (dB)

    Time frame: Within two weeks of admission

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

  2. Measurement of liver stiffness(kPa)

    Time frame: 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.

  3. blood platelet count(×10⁹/L)

    Time frame: Within two weeks of admission

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

  4. sensitivity and specificity

    Time frame: 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).

  5. Positive predictive value (PPV) and negative predictive value (NPV)

    Time frame: 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

  6. AUC

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

    Comprehensively reflect the overall discriminative ability of the model under different thresholds

Study contacts

Contact information is provided by the study sponsor or research team.

Dezhi Zhang, doctorate

CONTACT

[email protected]

0431-88782190

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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