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

Not Applicable

Not yet recruiting

• Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

• Registration Number: NCT07151885
• Lead Sponsor: The First Hospital of Jilin University

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study Start: 2025-08-31
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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