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New ultrasound technique could replace needle biopsy for liver disease

NCT ID NCT07588854

Diagnosis Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

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Recruiting now This study
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new endoscopic ultrasound method (EUS-SWQ) to measure liver stiffness and diagnose liver fibrosis (scarring) in people with chronic liver disease. Researchers will compare EUS-SWQ results with standard liver biopsy and FibroScan in 65 adults. The goal is to see if EUS-SWQ is accurate, safe, and easier for patients.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic liver disease (CLD) Liver fibrosis

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

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

    RECRUITING

    Shanghai, China

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