Spleen Ultrasound Test for Liver Scarring and Enlarged Veins
Studies a spleen ultrasound scan to assess liver-related portal hypertension and high-risk varices in adults.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- 2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices
- Status
- Recruiting
- People taking part
- 450 people, planned
- Started
- 20 Aug 2025
- Expected to end
- 20 Aug 2027
- Type of study
- Observational
- Record updated
- 25 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced chronic liver disease who still have good liver function and high liver stiffness on a scan. A spleen ultrasound scan is added to their routine exam.
- Age
- Older than 18 years
- Sex
- All sexes can join
- Disease stage
- Advanced chronic liver disease with high liver stiffness: SWE-LSM 9 kPa or more and/or TE-LSM 15 kPa or more
- Earlier treatment
- No prior treatment is required. People with a history of variceal bleeding cannot join.
- Biomarker or test result
- Liver stiffness on scan: SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa
Main reasons for not taking part
- A transjugular intrahepatic porto-systemic shunt (TIPS)
- The spleen was removed by surgery
- Grade 3 ascites
- A history of variceal bleeding
- Refusing to take part in the study
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Age greater than 18 years
- SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa
Who cannot take part
- Surgical absence of the spleen
- History of variceal bleeding
- Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
- Grade 3 ascites
- Refusal to participate in the study
Where in Italy
- Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"Roma, ItalyContact: GarcovichTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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.
- Plain-language title
- Spleen Ultrasound Test for Liver Scarring and Enlarged VeinsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 November 2025