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

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine65 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Liver Disease (CLD)Liver Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks after the intervention

Secondary Outcomes

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.

Time frame: At baseline

Safety and measurement success rate of EUS-SWQ

To evaluate the safety and technical success rate of EUS-SWQ measurement in patients with chronic liver disease.