Spleen stiffness measurement to detect advanced liver fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: luca.miele@policlinicogemelli.it
• Phone: +390630157717

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.