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Recruiting NCT07440511

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

— Observational MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis and Prognostication in Patients With Metabolic-dysfunction Associated SteatoHepatitis

Overview

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.

Primary outcome measures

  • The predictive value of baseline LSM and SSM [Time frame: From January 2026 to January 2033]
Secondary outcome measures (1)
  • The diagnostic performance of spleen stiffness measurement [Time frame: From January 2026 to January 2033]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Identifiers

NCT: NCT07440511 · 7761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗