Actively Recruiting

Age: 18Years +
All Genders
ID07122622

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-11-25

450

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of spleen shear wave elastography (SWE-SSM) to diagnose clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and to identify high-risk esophageal varices (HRV) in those with CSPH. The study also aims to examine how SWE-SSM correlates with portal pressure in certain patients undergoing hepatic venous pressure gradient (HVPG) measurements and with transient elastography (TE-SSM). During routine ultrasound examinations required by the patient's care plan, values of SWE-SSM and liver shear wave elastography (SWE-LSM) will be measured. If patients meet the inclusion criteria and provide informed consent, an additional spleen elastography will be performed as a non-invasive diagnostic test without changing the standard ultrasound procedure or affecting the patient's treatment or disease progression. Participants will undergo ultrasound assessments where spleen and liver elastography data are collected. The study will not introduce any treatment or intervention that alters the patient's condition. Researchers will monitor and analyze these measurements to better understand CSPH and high-risk varices over a 2-year period, focusing on the primary outcome related to CSPH.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • SWE-LSM greater than or equal to 9 kPa and/or TE-LSM greater than or equal to 15 kPa
Not Eligible

You will not qualify if you...

  • Having a transjugular intrahepatic porto-systemic shunt (TIPS)
  • Surgical removal of the spleen
  • Having grade 3 ascites
  • History of variceal bleeding
  • Refusal to participate in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, Italy, 00168

Actively Recruiting

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Research Team

M

Matteo Garcovich doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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