Endoscopic ultrasound shear wave elastography for measuring liver fibrosis
Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
This study will test whether endoscopic ultrasound shear wave elastography and attenuation imaging can estimate liver fibrosis compared with biopsy and FibroScan in adults with suspected MASLD or MASH.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Olympus Corporation of the Americas Industry-sponsored |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06592820 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, single-arm, consecutive registry enrolling up to 300 adults with suspected MASLD or MASH who are scheduled for endoscopic ultrasound with liver biopsy. Participants will undergo EUS with shear wave elastography (SWE) and attenuation imaging (ATI), a FibroScan (VCTE), and liver biopsy, with FibroScan and biopsy performed within three months of the EUS. The study will compare EUS-SWE and ATI measurements to histologic fibrosis staging and FibroScan results to establish optimal EUS-SWE cutoffs and diagnostic performance. Data will be collected at up to six U.S. sites over an expected 18-month enrollment period and analyzed against predefined protocol procedures.
Who should consider this trial
Good fit: Adults aged 18 or older with clinical suspicion of MASLD or MASH, BMI ≥28, and who are scheduled to undergo EUS with liver biopsy and a FibroScan within three months are ideal candidates.
Not a fit: Patients who do not have a biopsy or FibroScan within the specified three-month window, who have BMI <28, or who lack clinical suspicion of MASLD/MASH are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, EUS-SWE and ATI could provide accurate, less invasive measures of liver fibrosis and reduce reliance on repeated liver biopsies.
How similar studies have performed: Transabdominal elastography methods like FibroScan and conventional shear wave elastography have established utility, but EUS-based SWE and ATI are relatively novel with limited prior validation against liver biopsy.
Eligibility criteria
Show full inclusion / exclusion 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 6. Prior history of or current excess alcohol consumption (\>140 g/week and \>210 g/week for females and males, respectively) documented in EMR
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Marvin Ryou, MD — Brigham and Women's Hospital, Boston, MA
- Study coordinator: Octavia Plingu
- Email: octavia.plingu@olympus.com
- Phone: 4089413623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.