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Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

ConditionsPortal Vein ThrombosisPortal Hypertension Related to Cirrhosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

History of liver cirrhosis

INR < 1.5

Platelet count > 50 × 10⁹/L

Disqualifiers

Patients with ascites

Patients with renal insufficiency

Patients with active infection

Patients with hepatic encephalopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • endoscopic ultrasound-guided portal pressure gradient

    Procedure/Surgery

    This study employs an integrated endoscopic ultrasound-guided portal pressure gradient (EUS-PPG+) protocol uniquely designed for cirrhotic patients with portal vein thrombosis (PVT). Under general anesthesia in the left lateral decubitus position (novel positioning), a linear echoendoscope directs 22G needle puncture of the portal vein and inferior vena cava for direct pressure measurement, with real-time Doppler confirmation to avoid thrombosed vessels. Crucially, this intervention synchronizes diagnostic and therapeutic actions: if high-risk esophageal/gastric varices are identified during EUS, immediate endoscopic therapy (e.g., glue injection) is delivered in the same session. All participants additionally undergo standard hepatic venous pressure gradient (HVPG) measurement via transjugular access within 24 hours, enabling within-patient correlation analysis.

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: hepatic venous pressure gradient, HVPGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques

The internal jugular vein is punctured and the difference between the wedge hepatic venous pressure (WHVP) and the free hepatic venous pressure (FHVP) is measured as the hepatic venous pressure gradient (HVPG). Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) refers to the measurement of data by passing the puncture needle through the digestive tract into the portal vein system, hepatic vein or inferior vena cava system under the guidance of a linear array ultrasound endoscope.Portal vein pressure (PVP): The normal portal vein pressure is 1.27-2.35 kPa (13-24 cmH2O)

Time frame
From enrollment, treatment was completed within 1 week

Secondary outcomes

1

Incidence of surgery-related complications

Complications: obvious abdominal pain and nausea, fever \> 38.5°C

Time frame
From enrollment, treatment was completed within 1 week
2

Direct medical cost of treatment

Direct medical cost of treatment: Components: surgical consumables, anesthesia, drugs, ward fees, nursing Currency: RMB (yuan)

Time frame
From enrollment, treatment was completed within 1 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Source ClinicalTrials.gov

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