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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Baiwen Li, MD
- 전화번호: 86-21-37798480
- 이메일: muzibowen@126.com
연구 장소
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Shanghai, 중국
- 모병
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation between EUS-SWQ measurements and METAVIR liver fibrosis staging
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Comparison of correlation with liver fibrosis between EUS-SWQ and FibroScan
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Baiwen Li, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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