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

Recruiting now

Conditions studied: Portal Hypertension Related to Cirrhosis, Esophageal Varices

In brief

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.

Key facts

Study ID

NCT07122622

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

450

Starts

2025-08-20

Expected to finish

2027-08-20

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18 years;
• SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;

You may not qualify if…

• 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.

Where it is running

• Ultrasound diagnostic and interventional service "Policlinico A.Gemelli" — Roma, Italia, Italy (enrolling)

Full record on ClinicalTrials.gov

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