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Clinical Trials in Italy / NCT07440511
Recruiting Observational

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

NCT07440511 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2026-01-28
Last updated
2026-02-27

Condition(s) studied

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Study summary

Measurement of spleen stiffness (SSM) has shown potential as a complementary tool to liver stiffness measurement (LSM) for the assessment of portal hypertension in patients with MASLD, particularly in the setting of compensated advanced chronic liver disease (cACLD). The 100-Hz probe for SSM, developed more recently, improves the accuracy of spleen stiffness measurements by better capturing the specific characteristics of the splenic parenchyma. This method has been shown to correlate well with HVPG, the gold standard for the assessment of portal hypertension, and has demonstrated good predictive value for the detection of high-risk varices, which are indicative of advanced liver disease.

The correlation between SSM and other clinical markers, such as spleen size and platelet count, has proven to be strong, further supporting its utility in assessing disease progression. This makes SSM a promising non-invasive tool for early detection and risk stratification in MASLD, which is crucial for preventing progression to more severe stages such as cirrhosis or hepatocellular carcinoma.

In conclusion, the combined use of LSM and SSM shows great potential for improving the non-invasive diagnosis and monitoring of MASLD, providing an efficient alternative to more invasive methods such as liver biopsy and HVPG. This evidence has led to the inclusion of SSM use in clinical guidelines for the management of patients with chronic liver disease. Nevertheless, further studies are needed to confirm these findings and to refine clinical protocols, potentially allowing earlier intervention and improved management of patients with MASLD and its complications.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • The predictive value of baseline LSM and SSM — From January 2026 to January 2033
    The assessment of the predictive value of baseline LSM and SSM, as well as their changes over time, for the incidence of major adverse liver outcomes (MALOs) in patients with MASLD and advanced chronic liver disease (ACLD).

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07440511 on ClinicalTrials.gov ↗ ← All trials in Italy