Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

NCT07440511 | Recruiting

• 1 other identifier: 7761
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The diagnostic performance of spleen stiffness measurement

  From January 2026 to January 2033

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Study Officials

• Luca Miele

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Miele, MD

CONTACT

+390630157717; luca.miele@policlinicogemelli.it

Antonio Liguori, MD

CONTACT

antonio.liguori@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOS Pre Liver Trasplant

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 27, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2033
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (1)