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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve early detection of serious liver disease in individuals with fatty liver disease. Researchers will measure spleen stiffness, which may indicate the severity of liver disease. The study employs vibration-controlled transient elastography, a tool for assessing organ stiffness, to examine both the liver and spleen. Individuals diagnosed with fatty liver disease through prior tests or medical records are suitable candidates for this trial. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance early detection methods for liver disease.

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 prior data suggests that this method is safe for measuring spleen stiffness?

Research has shown that vibration-controlled transient elastography (VCTE) is generally safe and easy to use. Medical settings often employ this method to assess liver stiffness without invasive procedures.

Studies have found that VCTE effectively predicts liver problems in individuals with fatty liver disease. No serious side effects have been reported from using this method. It operates by sending gentle vibrations through a device to the skin over the liver and spleen to measure stiffness.

Overall, this technique is considered low-risk, providing a reliable way to monitor liver health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using vibration-controlled transient elastography for fatty liver disease because it offers a non-invasive way to measure liver and spleen stiffness, which can be crucial for early detection and monitoring of the disease. Unlike traditional liver biopsies, which are invasive and can be uncomfortable, this technique uses painless vibrations to assess organ stiffness, making it more patient-friendly. This method could lead to quicker, more frequent assessments, potentially improving patient outcomes by allowing for timely interventions.

What evidence suggests that measuring spleen stiffness is effective for detecting serious liver disease in fatty liver patients?

Research has shown that vibration-controlled transient elastography (VCTE) benefits people with fatty liver disease. In this trial, participants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using VCTE. Studies have found that VCTE scores accurately predict liver-related issues, helping to identify potential liver problems early. This non-invasive test does not involve surgery and effectively detects liver stiffness and scarring. Early detection of liver problems is crucial, as it can prevent serious health issues. Overall, VCTE offers a promising method to assess liver health in individuals with liver disease related to metabolic problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Nicholas Hoppmann, MD

Principal Investigator

Columbia VA Healthcare System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816449

Vibration-Controlled Transient Elastography Scores to ... Meaning Findings of this study suggest that the VCTE-based scores are generally accurate for predicting liver-related events, making them ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10958386/

Vibration-Controlled Transient Elastography Scores to ... Vibration-controlled transient elastography scores to predict liver-related events in steatotic liver disease.

3. e-cmh.org e-cmh.org/upload/pdf/cmh-2024-1131.pdf

Vibration-Controlled Transient Elastography in Shaping the ... Steatotic Liver Disease (SLD) has emerged as a growing concern, closely linked to increased cardiovascular risk and adverse outcomes, with substantial long-term.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38512249/

Vibration-Controlled Transient Elastography Scores to ... Findings of this study suggest that single or serial Agile scores are highly accurate in predicting LREs in patients with MASLD, ...

5. cghjournal.org cghjournal.org/article/S1542-3565(20)30444-4/fulltext

Diagnostic Performance of Vibration-Controlled Transient ... VCTE is a non-invasive tool for detecting hepatic steatosis and fibrosis in patients who have not received liver transplants.

6. cghjournal.org cghjournal.org/article/S1542-3565(24)00590-1/abstract

Vibration-Controlled Transient Elastography–Based ... Vibration-controlled transient elastography (VCTE) is used in clinical practice to risk-stratify liver transplant (LT) recipients.