See if EUS-SWQ can accurately detect and grade liver fibrosis in adults with chronic liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will compare EUS-SWQ measurements with liver biopsy pathology (METAVIR F0-F4) and with FibroScan in adults with chronic liver disease who are already scheduled for a clinically indicated liver biopsy. Participants will undergo EUS-SWQ and FibroScan prior to biopsy to assess diagnostic concordance, safety, and the rate of successful measurements. The goal is to determine if EUS-SWQ can accurately stage fibrosis and how it compares to existing noninvasive methods. The study will provide data on feasibility, potential clinical utility, and safety of the EUS-SWQ approach in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Baiwen Li, MD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Baiwen Li, MD
• Email: muzibowen@126.com
• Phone: 86-21-37798480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.