Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

Zhejiang University

Status: Not yet enrolling

Conditions: Portal Vein Thrombosis; Portal Hypertension Related to Cirrhosis

Treatments: Procedure: endoscopic ultrasound-guided portal pressure gradient

Study type: Interventional

Funder types: Other

Identifiers

NCT07062289

2025-0823

Details and patient eligibility

About

This study aims to evaluate the accuracy and safety of a novel endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement technique in 42 adults with liver cirrhosis and portal vein thrombosis (blood clots in the liver's main vein), a condition where current standard testing (HVPG) fails to provide reliable pressure readings. Participants will undergo both EUS-PPG (using a specialized needle under ultrasound guidance) and HVPG procedures to compare results; EUS-PPG will be performed under general anesthesia in a left-side lying position-an innovative approach-while also enabling immediate endoscopic treatment of bleeding veins if detected during the same session. The primary goals are to validate EUS-PPG's safety in this high-risk group, establish its correlation with HVPG, and pioneer an integrated diagnosis-treatment protocol to reduce hospital stays and costs. The study runs from July 2025 to June 2027 at Zhejiang University School of Medicine.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• History of liver cirrhosis
• INR < 1.5
• Platelet count > 50 × 10⁹/L
• Patients agreed to HVPG and EUS-PPG measurements

Exclusion criteria

• Patients with ascites
• Patients with renal insufficiency
• Patients with active infection
• Patients with hepatic encephalopathy
• Critically ill patients
• Pregnant patients
• Patients with immunodeficiency diseases (such as systemic lupus erythematosus)
• Patients with mental illness
• Patients with malignant tumors
• Patients who refused to undergo HVPG and EUS-PPG measurements

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

hepatic venous pressure gradient, HVPG

Experimental group

Description:

After puncturing the internal jugular vein, under the guidance of the image monitor, the balloon catheter is inserted into the hepatic vein along the blood vessel to measure the free hepatic venous pressure (FHVP), and then the balloon is inflated to measure the wedged hepatic venous pressure (WHVP). The difference between the two is the hepatic venous pressure gradient.

Treatment:

Procedure: endoscopic ultrasound-guided portal pressure gradient