2D-shear wave spleen elastography to detect clinically significant portal hypertension and high-risk esophageal varices
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.
This study tests whether a 2D-shear wave spleen ultrasound can rule in or rule out clinically significant portal hypertension and high‑risk esophageal varices in adults with advanced chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Italia) |
| Trial ID | NCT07122622 on ClinicalTrials.gov |
What this trial studies
This is an observational study that adds 2D-shear wave spleen elastography (SWE-SSM) to routine ultrasound examinations in eligible patients with compensated advanced chronic liver disease. Spleen and liver stiffness values (SWE-SSM and SWE-LSM, and transient elastography when available) will be recorded without altering standard care and compared to clinical markers of portal hypertension. A subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement will allow direct correlation between spleen stiffness and portal pressure. Participants are enrolled at Policlinico A. Gemelli in Rome and must meet predefined liver stiffness cutoffs while excluding conditions such as TIPS, splenectomy, grade 3 ascites, or prior variceal bleeding.
Who should consider this trial
Good fit: Adults over 18 with compensated advanced chronic liver disease and elevated liver stiffness (SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa) who have not had variceal bleeding and do not have TIPS or splenectomy are ideal candidates.
Not a fit: Patients with prior variceal bleeding, transjugular intrahepatic porto-systemic shunts (TIPS), surgical absence of the spleen, grade 3 ascites, or other significant decompensation are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, reliable spleen elastography could reduce the need for invasive pressure measurements and better identify who needs endoscopic surveillance for varices.
How similar studies have performed: Previous studies have shown promising correlations between spleen stiffness measurements and portal pressure, but techniques and cutoff values are not yet universally established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, Italia
- Ultrasound diagnostic and interventional service "Policlinico A.Gemelli" — Roma, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Matteo Garcovich doctor
- Email: matteo.garcovich@policlinicogemelli.it
- Phone: 0039 0630156018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.