EU-ME3 Endoscopic Ultrasound Shear Wave Quantification (EUS-SWQ) for Evaluating Liver Fibrosis and Histopathology in Patients With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Baiwen Li
Principal Investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine