Chronic Liver Disease (CLD)EUS-SWQ-202601NCT07588854
Correlation Of EUS-SWQ And Liver Fibrosis Pathology In Chronic Liver Disease
An observational study of Chronic Liver Disease (CLD) and Liver Fibrosis, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Liver Disease (CLD), Liver Fibrosis
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Jan 2028
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: 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:
Read more
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
- Chronic Liver Disease (CLD), Liver Fibrosis
- Keywords
- Chronic liver disease, Liver fibrosis, EUS-SWQ, Endoscopic ultrasound, Liver biopsy, FibroScan, Olympus EU-ME3
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after the intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease (CLD)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Baiwen Li, MD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588854
- Sponsor's protocol ID
- SH1HY-EUS-SWQ-20260123
- Acronym
- EUS-SWQ-202601
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT07588854
- Acronym / sponsor ID
- EUS-SWQ-202601 / SH1HY-EUS-SWQ-20260123
- Conditions
- Chronic Liver Disease (CLD), Liver Fibrosis
- Keywords
- Chronic liver disease, Liver fibrosis, EUS-SWQ, Endoscopic ultrasound, Liver biopsy, FibroScan, Olympus EU-ME3
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan
Time frame: At baseline
Safety and measurement success rate of EUS-SWQ
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baiwen Li, MD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease (CLD) and Liver Fibrosis, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baiwen Li, MD (86-21-37798480, muzibowen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging (time frame: 2 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.