Spleen Stiffness Measurement for Fatty Liver Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Jennings Bryan Dorn VA Medical Center

Disqualifiers: Pregnancy, Decompensated cirrhosis, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Vibration-controlled transient elastography for fatty liver disease?

Vibration-controlled transient elastography is effective in measuring liver stiffness and fat content in patients with non-alcoholic fatty liver disease, with a low failure rate of 3.2% in obtaining valid results, indicating its reliability as a noninvasive assessment tool. ^{1 2 3 4 5}

Is vibration-controlled transient elastography safe for humans?

Vibration-controlled transient elastography is generally considered safe for humans, with studies showing a low failure rate and no mention of harmful side effects in the research provided. ^{1 3 4 6 7}

How does vibration-controlled transient elastography differ from other treatments for fatty liver disease?

Vibration-controlled transient elastography is unique because it non-invasively measures liver stiffness using vibrations, providing a practical alternative to liver biopsies for monitoring non-alcoholic fatty liver disease over time. ^{3 6 8 9 10}

What is the purpose of this trial?

A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.

Research Team

Nicholas Hoppmann, MD

Principal Investigator

Columbia VA Healthcare System

Eligibility Criteria

This trial is for veterans with fatty liver disease, including those with metabolic dysfunction-associated steatotic liver disease. It aims to find early signs of serious liver conditions by measuring spleen stiffness.

Inclusion Criteria

Able to read and comprehend English

Able to consent for participation in a clinical study

Evidence of fatty liver disease on previous liver biopsy, imaging, or clinical documentation

Exclusion Criteria

Pregnant

I am unable to understand and agree to the study's details on my own.

I have advanced liver disease or liver cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants undergo liver and spleen stiffness measurements using vibration-controlled transient elastography

1 year

Follow-up

Participants are monitored for safety and effectiveness after measurements

4 weeks

Treatment Details

Interventions

• Vibration-controlled transient elastography

Trial Overview The study tests the effectiveness of vibration-controlled transient elastography, a non-invasive method to measure spleen stiffness and detect potential progression towards severe liver disease in patients with fatty liver.

Participant Groups

Group I: Spleen Stiffness Measurements Experimental Treatment 1 Intervention

Participants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using vibration-controlled transient elastography

Who Is Running the Clinical Trial?

William Jennings Bryan Dorn VA Medical Center

Lead Sponsor

Trials

6

Recruited

1,900+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Performance of transient elastography (TE) and factors associated with discordance in non-alcoholic fatty liver disease. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transient Elastography in the Diagnosis of Pediatric Non-alcoholic Fatty Liver Disease and Its Subtypes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Is Fasting Necessary for Individuals With Nonalcoholic Fatty Liver Disease to Undergo Vibration-Controlled Transient Elastography? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Performance characteristics of vibration-controlled transient elastography for evaluation of nonalcoholic fatty liver disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Liver stiffness (Fibroscan®) is a predictor of all-cause mortality in people with non-alcoholic fatty liver disease. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of 10-year changes in liver stiffness using vibration-controlled transient elastography in non-alcoholic fatty liver disease. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Assessment of Liver Fibrosis in NAFLD. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Acoustic radiation force impulse (ARFI) elastography of the spleen in healthy adult cats--a preliminary study. [2016]

9. Japan pubmed.ncbi.nlm.nih.gov

Elucidation of spleen elasticity and viscosity in a carbon tetrachloride rat model of liver cirrhosis using a new ultrasound elastography. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

US Time-Harmonic Elastography: Detection of Liver Fibrosis in Adolescents with Extreme Obesity with Nonalcoholic Fatty Liver Disease. [2018]