Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Diagnostic adequacy of the tissue sample
研究概览
简要总结
This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.
详细描述
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
The pathologist will be blinded to the procedure received by the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred for liver biopsy for any reason
- •Informed consent obtained from the patient
- •≥ 18 years old
- •Able to undergo conscious sedation for EUS procedure
排除标准
- •<18 years old
- •Unable to obtain informed consent from the patient
- •Medically unfit for sedation
- •Pregnant patients
- •Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
- •Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
- •Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
- •Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination
结局指标
主要结局
Diagnostic adequacy of the tissue sample
时间窗: 24 hours
The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.
次要结局
- Pain scores(24 hours, 1 week, 30 days)
- Procedure duration(24 hours)
- Rate of adverse events(24 hours, 1 week, 30 days)
- Procedural costs(30 days)
- Specimen length(24 hours)
- Portal tracts(24 hours)
- Rates of specimen adequacy(24 hours)
- Cross over(1 week, 30 days)