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

Jilin University

Status: Not yet enrolling

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

Treatments: Diagnostic Test: SHAPE

Study type: Interventional

Funder types: Other

Identifiers

NCT07151885

2025-MS-306

Details and patient eligibility

About

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)

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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380 participants in 1 patient group

SHAPE

Experimental group

Description:

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:

Diagnostic Test: SHAPE