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Study identifier: NCT07440511 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

Condition: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhaseN/A
Planned participants500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Luca Miele, MD  ·  +390630157717  ·  luca.miele@policlinicogemelli.it

Antonio Liguori, MD  ·  antonio.liguori@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCSRome, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07440511