Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease

EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease

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.

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.