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

Inclusion Criteria2

  • Age greater than 18 years;
  • SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;

Exclusion Criteria5

  • Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
  • Surgical absence of the spleen;
  • Grade 3 ascites;
  • History of variceal bleeding;
  • Refusal to participate in the study.

Locations(1)

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, Italy

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NCT07122622


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