Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"
Roma, Italia, Italy, 00168
Actively Recruiting
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