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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Baiwen Li, MD
- Telefonnummer: 86-21-37798480
- E-Mail: muzibowen@126.com
Studienorte
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Shanghai, China
- Rekrutierung
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging
Zeitfenster: 2 weeks after the intervention
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To assess the correlation between EUS-SWQ measurements and liver fibrosis pathology stages (METAVIR F0-F4) using liver biopsy as the reference standard.
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2 weeks after the intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan
Zeitfenster: At baseline
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To compare the correlation of EUS-SWQ and FibroScan measurements with histologically confirmed liver fibrosis stages.
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At baseline
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Safety and measurement success rate of EUS-SWQ
Zeitfenster: At baseline
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To evaluate the safety and technical success rate of EUS-SWQ measurement in patients with chronic liver disease.
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At baseline
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Baiwen Li, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SH1HY-EUS-SWQ-20260123
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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