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Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

Recruitingn/aAges 18 Years - anyAllFondazione Policlinico Universitario Agostino Gem…
NCT07440511 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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