Shear Wave Elastography Registry Study

Launched by OLYMPUS CORPORATION OF THE AMERICAS · Sep 9, 2024

Keywords

ClinConnect Summary

The Shear Wave Elastography Registry Study is a clinical trial aimed at comparing two methods for assessing liver stiffness, which helps doctors understand liver health, particularly in patients with chronic liver diseases like MASLD and MASH. This study will involve patients who are scheduled for an ultrasound and liver biopsy to evaluate liver fibrosis. The researchers will look at the effectiveness of a special imaging technology called ShearWave Elastography compared to another method known as FibroScan.

To participate in the trial, individuals must be at least 18 years old, willing to give consent, and have a body mass index (BMI) of 28 or higher. They should also have a clinical suspicion of liver conditions related to metabolic issues and be scheduled for a liver biopsy either during or within three months of the ultrasound. Participants will not be eligible if they have certain liver conditions or previous surgeries that affect liver imaging. Those who join the study can expect to undergo both the ultrasound and the biopsy as part of their routine care, and their experiences will help improve how liver diseases are diagnosed and managed in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years of age or older
• • 2. Willing and able to provide informed consent
• • 3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
• • 4. Patient scheduled to undergo or have undergone Fibroscan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
• • 5. BMI \>/=28
• • 6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, Fibroscan)
• Exclusion Criteria:
• • 1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
• • 2. Prior history of Hepatitis B or C infection
• • 3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
• • 4. Histological evidence of other concomitant chronic liver disease on biopsy
• • 5. Inadequate liver biopsy