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

Recruitingn/aAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT07122622 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age greater than 18 years; * SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa; Exclusion Criteria: * 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.
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What it tests

  • Not listed
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Where

1 site
Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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