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

NCT07588854 | Recruiting

• 1 other identifier: SH1HY-EUS-SWQ-20260123
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Fibrosis; Chronic Liver Disease (CLD)

Keywords

Chronic liver disease; Liver fibrosis; EUS-SWQ; Endoscopic ultrasound; Liver biopsy; FibroScan; Olympus EU-ME3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  At baseline

• Safety and measurement success rate of EUS-SWQ

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baiwen Li, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baiwen Li, MD

CONTACT

86-21-37798480; muzibowen@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-01

Locations

CN (1)