Actively Recruiting

Age: 18Years +
All Genders
NCT07440511

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-27

500

Participants Needed

1

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Spleen Stiffness Measurement for the Detection of Advanced Fibrosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) according to EASL guidelines
  • Confirmed compensated advanced chronic liver disease (fibrosis stage F3-F4) by liver biopsy or non-invasive liver stiffness measurement (LSM > 15 kPa), OR suspected cACLD based on non-invasive tests (LSM > 8 kPa) leading to or justifying liver biopsy
  • Signed informed consent for participation in the prospective cohort
Not Eligible

You will not qualify if you...

  • Other liver diseases including viral, autoimmune, cholestatic, drug-induced, alcohol-related liver disease, or use of hepatotoxic drugs such as long-term corticosteroids, estrogen-progestin therapy, methotrexate, or valproic acid
  • Presence of primary or secondary liver cancer
  • Previous hepatic decompensation
  • Hematological disorders
  • Portal vein thrombosis
  • Previous transjugular intrahepatic portosystemic shunt (TIPS) placement
  • Previous liver transplantation
  • Current or past extrahepatic cancer within the last 5 years
  • Previous bariatric surgery within the last 3 years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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Research Team

L

Luca Miele, MD

CONTACT

A

Antonio Liguori, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Spleen Stiffness Measurement for the Detection of Advanced Fibrosis | DecenTrialz