Endoscopic Ultrasound Shear Wave Elastography Study

Recruiting

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

• Registration Number: NCT06592820
• Lead Sponsor: Olympus Corporation of the Americas

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-09
• Study Start: 2025-09-03
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-15
• Primary Completion: 2027-02-28
• Study Completion: 2027-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system	During study data analysis	Establish optimal cutoffs for EUS-SWE cutoffs in reference to liver biopsies on METAVIR staging system for significant fibrosis (F0-1 vs F2-4), advanced fibrosis (F0-2 vs F3-4), and cirrhosis (F0-3 vs F4) based on area under the receiver operator characteristics (AUROC) curve analysis.

Secondary Outcome Measures

Name	Time	Method
Correlation of EUS-SWE to fibrosis staging (from liver biopsy).	During study analysis	Evaluate the correlation of EUS-SWE to fibrosis staging (from liver biopsy).
SWE vs FibroScan and other non-invasive fibrosis screening modalities ( screening scores)	During study analysis	Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (e.g., Fibrosis-4 Score (FIB-4), AST to Platelet Ratio Index (APRI), and NAFLD Fibrosis Score (NFS)).
Correlation of EUS-ATI to steatosis score (from liver biopsy)	During study analysis	Evaluate the correlation of EUS-ATI to steatosis score (from liver biopsy).

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States