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NCT Number: NCT07440511

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

Luca Miele, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The predictive value of baseline LSM and SSM

    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).

Secondary outcomes

  1. The diagnostic performance of spleen stiffness measurement

    Time frame: From January 2026 to January 2033

    Diagnosis of cACLD based on liver biopsy as the diagnostic gold standard

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Liguori, MD

CONTACT

[email protected]

Luca Miele, MD

CONTACT

[email protected]

+390630157717

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: S-MASH

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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