Endoscopic Ultrasound Shear Wave Elastography Study (EUS-SWE)

Olympus

Status: Enrolling

Conditions: Fibrosis, Liver; Chronic Liver Disease; MASLD; MASH

Treatments: Device: FibroScan; Device: Liver biopsy; Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT06592820

2021-GI-02

Details and patient eligibility

About

This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question[s] it aims to answer are:

• Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis
• Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).

Participants will undergo:

• Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)
• Liver biopsy
• FibroScan

Full description

A total of up to 300 subjects will be enrolled and treated at up to six US sites. Enrollment is expected to be completed within 18 months. Each subject will undergo procedures (EUS with SW Elastography and Attenuation Imaging, liver biopsy and FibroScan). Liver biopsy and FibroScan should be done within three months from Endoscopic ultrasound with SWE and ATI. End of study participation for a subject will be reached after pathology results have been obtained.

This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. All consenting, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

All subjects enrolled

Description:

Consecutive, eligible patients reporting for an endoscopic ultrasound liver biopsy and FibroScan for evaluation of liver fibrosis will be enrolled. EUS-SWE/ATI will be compared to liver biopsy pathology results, FibroScan (VCTE and CAP) results, and screening scores).

Treatment:

Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging

Device: Liver biopsy

Device: FibroScan