Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168, Italy
Location status: Recruiting
NCT Number: NCT07440511
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rome, 00168, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: From January 2026 to January 2033
Diagnosis of cACLD based on liver biopsy as the diagnostic gold standard
Contact information is provided by the study sponsor or research team.
Antonio Liguori, MD
CONTACT
Luca Miele, MD
CONTACT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Spleen Stiffness Measurement for the Detection of Advanced Fibrosis and Prognostication in Patients With Metabolic-dysfunction Associated SteatoHepatitis
Acronym: S-MASH
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