RecruitingNCT07122622

2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices

Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

450 participants

Start Date

Aug 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM). The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition. There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an ultrasound technique called 2D shear wave elastography of the spleen can predict the presence of enlarged, dangerous veins (varices) in people with liver disease and high pressure in the portal vein (portal hypertension). **You may be eligible if...** - You are over 18 years old - You have elevated liver stiffness scores on certain tests (SWE-LSM ≥9 kPa or TE-LSM ≥15 kPa), suggesting liver disease and portal hypertension **You may NOT be eligible if...** - You have already had a TIPS procedure (a shunt placed in the liver to reduce portal pressure) - Your spleen has been surgically removed - You have severe abdominal fluid buildup (grade 3 ascites) - You have a history of bleeding from varices - You refuse to participate in the required follow-up procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, Italy

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NCT07122622


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