Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease

William Jennings Bryan Dorn VA Medical Center

Status: Invitation-only

Conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Treatments: Device: Vibration-controlled transient elastography

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06953830

1766537-1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to consent for participation in a clinical study
• Able to read and comprehend English
• Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation

Exclusion criteria

• Pregnant
• Known decompensated cirrhosis or hepatocellular carcinoma
• Absence of spleen
• Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
• Unable to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Spleen Stiffness Measurements

Experimental group

Description:

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

Treatment:

Device: Vibration-controlled transient elastography