Chronic Liver Disease (CLD), Liver Fibrosis
Conditions
Keywords
Chronic liver disease, Liver fibrosis, EUS-SWQ, Endoscopic ultrasound, Liver biopsy, FibroScan, Olympus EU-ME3
Brief 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.
Interventions
None listed
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years and ≤ 80 years. 2. Patients with clinical indications scheduled to undergo liver biopsy (EUS-guided) for the evaluation of liver lesions. Chronic liver disease meeting criteria for biopsy includes:Hepatitis B；Fatty liver disease；Autoimmune hepatitis；Other chronic liver diseases of unknown etiology that would benefit from liver biopsy 3. Planned to undergo EUS-SWQ and FibroScan examinations prior to biopsy. 4. Willing to provide and sign written informed consent.
Exclusion criteria
1. Patients unable to tolerate endoscopic procedures. 2. Patients with contraindications to endoscopy or anesthesia. 3. Coagulopathy (platelet count \< 50×10⁹/L, PT \> upper limit of normal by 3 seconds). 4. Patients with severe underlying diseases of the respiratory, cardiovascular, cerebrovascular, digestive, or hematologic systems, as well as those with psychiatric disorders. 5. Patients with surgically altered anatomy that precludes adequate EUS imaging of the hepatic parenchyma. 6. Patients with imaging findings suggestive of malignant liver tumors. 7. Pregnant or lactating women. 8. Patients with decompensated cirrhosis (gastrointestinal bleeding, ascites, encephalopathy). 9. Patients who refuse to participate in the clinical study. 10. Any other conditions deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging | 2 weeks after the intervention | To assess the correlation between EUS-SWQ measurements and liver fibrosis pathology stages (METAVIR F0-F4) using liver biopsy as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan | At baseline | To compare the correlation of EUS-SWQ and FibroScan measurements with histologically confirmed liver fibrosis stages. |
| Safety and measurement success rate of EUS-SWQ | At baseline | To evaluate the safety and technical success rate of EUS-SWQ measurement in patients with chronic liver disease. |
Countries
China
Contacts
CONTACTBaiwen Li, MD
PRINCIPAL_INVESTIGATORBaiwen Li, MD
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed