Correlation Of EUS-SWQ And Liver Fibrosis Pathology In 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.

Recruiting

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Key information

Conditions

Chronic Liver Disease (CLD) Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Liver Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years and ≤ 80 years.
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
Planned to undergo EUS-SWQ and FibroScan examinations prior to biopsy.
Willing to provide and sign written informed consent.

Exclusion criteria

Patients unable to tolerate endoscopic procedures.
Patients with contraindications to endoscopy or anesthesia.
Coagulopathy (platelet count < 50×10⁹/L, PT > upper limit of normal by 3 seconds).
Patients with severe underlying diseases of the respiratory, cardiovascular, cerebrovascular, digestive, or hematologic systems, as well as those with psychiatric disorders.
Patients with surgically altered anatomy that precludes adequate EUS imaging of the hepatic parenchyma.
Patients with imaging findings suggestive of malignant liver tumors.
Pregnant or lactating women.
Patients with decompensated cirrhosis (gastrointestinal bleeding, ascites, encephalopathy).
Patients who refuse to participate in the clinical study.
Any other conditions deemed inappropriate by the investigator.

Treatment and study plan

Primary outcomes

Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging

Time frame: 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 outcomes

Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan

Time frame: 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

Time frame: At baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Baiwen Li, MD

CONTACT

[email protected]

86-21-37798480

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: EUS-SWQ-202601

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 15, 2026
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed