Actively Recruiting
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
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-11-25
450
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of spleen shear wave elastography (SWE-SSM) to help diagnose significant portal hypertension and high-risk esophageal varices in patients with advanced compensated chronic liver disease. The study aims to understand how well SWE-SSM can identify these conditions without affecting patient treatment or disease progression. It also explores how SWE-SSM relates to portal pressure and transient elastography measurements in some patients. During the ultrasound exams that patients normally undergo, spleen elastography will be added if the patient meets study criteria and consents. This additional test is non-invasive and does not change the standard ultrasound procedure or patient care. No treatments or experimental interventions will be given, as the study focuses on collecting clinical data through observation. Participants will have ultrasound exams including both spleen and liver elastography as part of their usual care pathway. Researchers will evaluate measurements related to portal hypertension and esophageal varices over a two-year period. The study monitors the natural course of the disease and gathers data without altering treatments or clinical management.
CONDITIONS
Brief 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 9 kPa and/or TE-LSM 15 kPa
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment period
Participants undergo 2D-shear Wave Spleen Elastography assessments to evaluate portal hypertension and varices.
1 visit (in-person)
Duration - Up to 2 years
Participants are monitored for clinically significant portal hypertension and high-risk varices over time.
Periodic visits during 2 years
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
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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