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Not yet recruiting NCT07062289

Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

No phase Interventional Portal Vein Thrombosis Portal Hypertension Related to Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic ultrasound-guided portal pressure gradient.
Who it may be relevant to
Registry conditions: Portal Vein Thrombosis, Portal Hypertension Related to Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure endoscopic 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

Primary outcome measures

  • Mean Portal Pressure Gradient Measured by HVPG and EUS-PPG Techniques [Time frame: From enrollment, treatment was completed within 1 week]
Secondary outcome measures (2)
  • Incidence of surgery-related complications [Time frame: From enrollment, treatment was completed within 1 week]
  • Direct medical cost of treatment [Time frame: From enrollment, treatment was completed within 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Martinez-Moreno B, Martinez Martinez J, Herrera I, Guilabert L, Rodriguez-Soler M, Bellot P, Miralles C, Pascual S, Irurzun J, Zapater P, Palazon-Azorin JM, Gil Guillen V, Jover R, Aparicio JR. Correlation of endoscopic ultrasound-guided portal pressure gradient measurements with hepatic venous pressure gradient: a prospective study. Endoscopy. 2025 Jan;57(1):62-67. doi: 10.1055/a-2369-0759. Epub PMID 39025130
  • Zhang W, Peng C, Zhang S, Huang S, Shen S, Xu G, Zhang F, Xiao J, Zhang M, Zhuge Y, Wang L, Zou X, Lv Y. EUS-guided portal pressure gradient measurement in patients with acute or subacute portal hypertension. Gastrointest Endosc. 2021 Mar;93(3):565-572. doi: 10.1016/j.gie.2020.06.065. Epub 2020 Jun 29. PMID 32615178

Identifiers

NCT: NCT07062289 · 2025-0823

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗