NCT07122622 2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices
| NCT ID | NCT07122622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Portal Hypertension Related to Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2027-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2025-08-20 with a primary completion date of 2027-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07122622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Portal Hypertension Related to Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07122622 currently recruiting?
Yes, NCT07122622 is actively recruiting participants. Contact the research team at matteo.garcovich@policlinicogemelli.it for enrollment information.
Where is the NCT07122622 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07122622 clinical trial?
NCT07122622 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 450 participants.