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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One cohort of 65 adult patients with chronic liver disease who are scheduled to undergo clinically i | Sixty-five patients with chronic liver disease who are scheduled to undergo clinically indicated liver biopsy. Only clinically indicated examinations including EUS-SWQ, FibroScan, and liver biopsy will be performed. No experimental drug or device intervention is administered in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging | To assess the correlation between EUS-SWQ measurements and liver fibrosis pathology stages (METAVIR F0-F4) using liver biopsy as the reference standard. | 2 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan | To compare the correlation of EUS-SWQ and FibroScan measurements with histologically confirmed liver fibrosis stages. | At baseline |
| Safety and measurement success rate of EUS-SWQ |
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Inclusion Criteria:
Exclusion Criteria:
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This is a single cohort observational study enrolling adult patients aged 18 to 80 years with chronic liver disease who meet clinical indications for EUS-guided liver biopsy. Candidates will undergo EUS-SWQ and FibroScan examinations before biopsy for the evaluation of liver fibrosis. Patients with contraindications to endoscopy, coagulopathy, severe comorbidities, decompensated cirrhosis, or suspected liver malignancy are excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baiwen Li, MD | Contact | 86-21-37798480 | muzibowen@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Baiwen Li, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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To evaluate the safety and technical success rate of EUS-SWQ measurement in patients with chronic liver disease. |
| At baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |