Actively Recruiting
EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-15
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Olympus EU-ME3 endoscopic ultrasound shear wave quantification (EUS-SWQ) function to diagnose and grade liver fibrosis in adults with chronic liver disease. The study aims to determine how closely EUS-SWQ measurements match liver fibrosis stages identified by liver biopsy, which is the standard method. It also compares EUS-SWQ results with FibroScan measurements and assesses the safety and success rate of EUS-SWQ in this setting. This is a prospective, single-center observational study involving 65 adult patients scheduled for clinically indicated liver biopsy. Participants will undergo EUS-SWQ and FibroScan examinations before the biopsy. These procedures are standard clinical tests, and no experimental drugs or devices are used. The study will monitor participants for any discomfort or adverse events related to the procedures. Participants will be assessed for liver fibrosis using liver biopsy pathology and EUS-SWQ measurements, with comparisons to FibroScan results. The primary outcome is the correlation between EUS-SWQ and liver fibrosis staging based on biopsy, evaluated two weeks after the intervention. Secondary outcomes include comparing the correlation of EUS-SWQ and FibroScan with liver fibrosis and the safety and measurement success rate of EUS-SWQ at baseline. The total participation duration covers the time needed for these examinations and follow-up assessments.
CONDITIONS
Brief Title
Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Adults with chronic liver disease scheduled for EUS-guided liver biopsy
- Diagnosed or suspected hepatitis B, fatty liver disease, autoimmune hepatitis, or other chronic liver diseases needing biopsy
- Planned to undergo EUS-SWQ and FibroScan examinations before biopsy
- Able and willing to provide written informed consent
You will not qualify if you...
- Unable to tolerate endoscopic procedures
- Contraindications to endoscopy or anesthesia
- Coagulopathy with platelet count less than 50×10⁹/L or prolonged prothrombin time by more than 3 seconds
- Severe diseases affecting respiratory, cardiovascular, cerebrovascular, digestive, or blood systems, or psychiatric disorders
- Surgically altered anatomy preventing adequate EUS imaging of the liver
- Imaging signs suggesting malignant liver tumors
- Pregnant or lactating women
- Decompensated cirrhosis with complications like bleeding, ascites, or encephalopathy
- Refusal to participate in the study
- Any condition considered inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo clinically indicated liver biopsy along with EUS-SWQ and FibroScan examinations to evaluate liver fibrosis.
1 visit (in-person)
Duration - 2 weeks
Participants are observed for safety and measurement success rate after the procedures.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
B
Baiwen Li, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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