Actively Recruiting

Age: 18Years +
All Genders
NCT07122622

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

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

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.

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, Italy, 00168

Actively Recruiting

Loading map...

Research Team

M

Matteo Garcovich doctor

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here