Spleen stiffness measurement to detect advanced liver fibrosis

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis and Prognostication in Patients With Metabolic-dysfunction Associated SteatoHepatitis

This study will test whether measuring spleen stiffness with a 100‑Hz probe can help detect advanced fibrosis and portal hypertension in adults with MASLD and compensated advanced chronic liver disease.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Rome)
• Trial ID: NCT07440511 on ClinicalTrials.gov

What this trial studies

This is an observational cohort of adults with MASLD and compensated advanced chronic liver disease who undergo spleen stiffness measurement using a 100‑Hz probe alongside routine liver stiffness measurements and clinical testing. The study compares spleen stiffness results with established markers such as liver stiffness, spleen size, platelet count, and clinical risk of varices to determine diagnostic value. The 100‑Hz probe is designed to better capture splenic tissue characteristics and has shown promising correlation with hepatic venous pressure gradient in prior work. No experimental treatments are administered; data come from noninvasive imaging and standard clinical assessments performed at the enrolling center.

Who should consider this trial

Good fit: Adults (over 18) with MASLD and confirmed or suspected compensated advanced chronic liver disease (by histology F3–F4 or by liver stiffness thresholds) who can give informed consent are eligible.

Not a fit: Patients with other liver disease causes (viral, autoimmune, alcohol-related, drug-induced), prior hepatic decompensation, prior TIPS or liver transplant, portal vein thrombosis, hematologic disorders, recent bariatric surgery, or recent extrahepatic cancer are excluded and unlikely to benefit from this test in this study.

Why it matters

Potential benefit: If successful, this approach could offer a more accurate, noninvasive way to identify patients with advanced fibrosis and clinically significant portal hypertension, potentially reducing the need for invasive testing.

How similar studies have performed: Previous studies of spleen stiffness have shown good correlation with hepatic venous pressure gradient and predictive value for high‑risk varices, though the newer 100‑Hz probe requires further validation.

Eligibility criteria

Inclusion Criteria:

* Age \> 18 years
* Diagnosis of MASLD according to EASL guidelines
* Presence of cACLD confirmed by histology (fibrosis F3-F4) or assessed non-invasively (LSM \> 15 kPa), OR suspected cACLD based on non-invasive tests (LSM \> 8 kPa) that leads to or has led to the indication for liver biopsy according to routine clinical practice
* Signed informed consent for the prospective cohort

Exclusion Criteria:

* Other etiologies of liver disease, including viral, autoimmune/cholestatic, drug-induced, alcohol-related liver disease (ALD), or use of hepatotoxic drugs (e.g. long-term oral corticosteroids, estrogen-progestin therapy, methotrexate, valproic acid)
* Primary or secondary liver cancer
* Previous hepatic decompensation
* Hematological disorders
* Portal vein thrombosis
* Previous TIPS placement
* Previous liver transplantation
* Current or past extrahepatic malignancy (\< 5 years)
* Previous bariatric surgery (\< 3 years)

Where this trial is running

Rome

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Luca Miele — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Luca Miele, MD

Conditions MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease