Endoscopic Ultrasound-guided Measurement of Portal Vein Pressure Gradient

NCT07062289 | Not Yet Recruiting

• 1 other identifier: 2025-0823
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Portal Vein Thrombosis; Portal Hypertension Related to Cirrhosis

Outcome Measures

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)

  From enrollment, treatment was completed within 1 week

Secondary Outcomes (2)

• Incidence of surgery-related complications

  From enrollment, treatment was completed within 1 week

• Direct medical cost of treatment

  From enrollment, treatment was completed within 1 week

Study Arms (1)

hepatic venous pressure gradient, HVPG

EXPERIMENTAL

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.

Procedure: endoscopic ultrasound-guided portal pressure gradient

Interventions

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.

hepatic venous pressure gradient, HVPG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Related Publications (2)

• 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 2024 Jul 18.

  PMID: 39025130 RESULT

• 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 RESULT

Central Study Contacts

Wei Wei

CONTACT

17530861504; wwze@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share