Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07062289

Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Portal Vein Thrombosis Portal Hypertension Related to Cirrhosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic ultrasound-guided portal pressure gradient

Procedure

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Incidence of surgery-related complications

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

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

  2. Direct medical cost of treatment

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

    Direct medical cost of treatment:

    Components: surgical consumables, anesthesia, drugs, ward fees, nursing Currency: RMB (yuan)

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Wei

CONTACT

[email protected]

17530861504

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Official study title

Study on the Measurement of Portal Vein Pressure Gradient Guided by Endoscopic Ultrasound Based on Portal Vein Thrombosis and Portal Hypertension

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.