Spleen Stiffness Measurement for the Detection of Advanced Fibrosis (S-MASH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Luca Miele, MD; Phone Number: +390630157717; Email: luca.miele@policlinicogemelli.it
• Study Contact Backup: Name: Antonio Liguori, MD; Email: antonio.liguori@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Luca Miele, MD; Email: luca.miele@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults (age > 18 years) with metabolic dysfunction-associated steatotic liver disease.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive value of baseline LSM and SSM	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).	From January 2026 to January 2033

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic performance of spleen stiffness measurement	Diagnosis of cACLD based on liver biopsy as the diagnostic gold standard	From January 2026 to January 2033

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Luca Miele, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2033

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 7761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No