2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices
NCT ID: NCT07122622
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2025-08-20
2027-08-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;
Exclusion Criteria
* Surgical absence of the spleen;
* Grade 3 ascites;
* History of variceal bleeding;
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Garcovich Matteo
Doctor
Locations
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Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"
Roma, Italia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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7514
Identifier Type: -
Identifier Source: org_study_id
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