Portal Hypertension Related to Cirrhosis, Portal Vein Thrombosis
Conditions
Brief summary
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.
Interventions
PROCEDUREendoscopic ultrasound-guided portal pressure gradient
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques | From enrollment, treatment was completed within 1 week | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgery-related complications | From enrollment, treatment was completed within 1 week | Complications: obvious abdominal pain and nausea, fever \> 38.5°C |
| Direct medical cost of treatment | From enrollment, treatment was completed within 1 week | Direct medical cost of treatment: Components: surgical consumables, anesthesia, drugs, ward fees, nursing Currency: RMB (yuan) |
Contacts
Primary ContactWei Wei
Outcome results
None listed