Actively Recruiting
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
Eligibility Criteria
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
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
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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