Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease
NCT07588854 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 65
Last updated 2026-05-15
Summary
The goal of this clinical study is to learn whether the Olympus EU-ME3 endoscopic ultrasound shear wave quantification (EUS-SWQ) function can accurately diagnose and grade liver fibrosis in patients with chronic liver disease. It will also learn about the safety and measurement success rate of EUS-SWQ.
The main questions it aims to answer are:
How closely do EUS-SWQ measurements match liver fibrosis stages determined by liver biopsy (the reference standard)? Does EUS-SWQ correlate better with liver biopsy results than FibroScan? How safe is EUS-SWQ and how often can successful measurements be obtained? Researchers will compare EUS-SWQ results with liver biopsy pathology (METAVIR F0-F4) and with FibroScan results to evaluate its diagnostic value.
Participants will:
Be adults with chronic liver disease who are scheduled to undergo a clinically indicated liver biopsy Undergo an EUS-SWQ examination as part of the study Have their liver stiffness measured by both EUS-SWQ and FibroScan for comparison Be monitored for any discomfort or adverse events related to the procedures A total of 65 participants will take part in this prospective, single-center, post-market clinical study.
Conditions
- Chronic Liver Disease (CLD)
- Liver Fibrosis
Sponsors & Collaborators
-
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Principal Investigators
-
Baiwen Li, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
Countries
- China
Study Locations
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