NCT07122622Recruiting
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.
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 20 Aug 2025
- Primary completion date
- 20 Aug 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- High blood pressure
- NCT number
- NCT07122622
What you commit to
- Study type: Observational
- Planned participants: 450
- From 20 Aug 2025 to the primary completion date, 20 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical absence of the spleen;
Other illness
- History of variceal bleeding;
Other
- Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
- Grade 3 ascites;
- Refusal to participate in the study.
Who the study is looking for
- Age greater than 18 years;
- SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ultrasound diagnostic and interventional service "Policlinico A.Gemelli" Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.