Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease (EUS-SWQ-202601)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Fibrosis; Chronic Liver Disease (CLD)

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Baiwen Li, MD; Phone Number: 86-21-37798480; Email: muzibowen@126.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Baiwen Li, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic ultrasound; Liver fibrosis; Liver biopsy; Chronic liver disease; FibroScan; EUS-SWQ; Olympus EU-ME3
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis
• Other Study ID Numbers: SH1HY-EUS-SWQ-20260123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No