Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- portal tracts obtained
研究概览
简要总结
Histopathological examination of liver tissue is used to determine the etiology and extent of liver disease. In order for a clinician to make a better-informed decision regarding a patient with liver disease, the liver biopsy specimen has to be adequate and of high quality for pathological interpretation. It is generally agreed that an adequate liver biopsy has to have ≥6-12 intact portal tracts for pathological review and interpretation.(1) Historically, three approaches have been used to obtain a liver biopsy: percutaneous, transjugular (TJ-LB) and laparoscopic approach (LA-LB)- with percutaneous liver biopsy (P-LB) being the most commonly employed. Endoscopic ultrasound-guided liver biopsy (EUS-LB), a newer approach, is now being performed by select skilled endoscopists across the country. EUS-LB is advantageous over existing techniques because it enables visualization and avoidance of vessels that are 1mm in diameter, provides access to both lobes of the liver and theoretically is less painful due to avoiding somatic pain fibers. Further, in patients that are already undergoing esophagogastroduodenoscopy, EUS-LB can be performed simultaneously and spare the patient an additional procedure. Because of the plausibility of reduced pain, number of procedures and possibly complications, EUS-LB may be cost-effective over existing methods. There is limited data evaluating the safety and efficacy of EUS-LB versus percutaneous liver biopsy.
The investigators hope to provide answers in a prospective study comparing between patients, who are already undergoing liver biopsy, randomly assigned to either EUS-LB or P-LB. The investigators will compare outcomes such as pain, bleeding, hospitalization, and tissue diagnosis between the two groups. This will allow us to add to the existing data for the use of EUS-LB. If patients are found to have less adverse events and better outcomes using EUS-LB versus percutaneous-LB this may become the preferred method of diagnosis in this patient population.
详细描述
Date: 01/03/2019 Version Number: 1 Principal Investigator: Ghassan Hammoud MD Application Number: 2011629 Application Title: Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies versus Percutaneous Liver Biopsies: A Randomized Clinical Trial.
Protocol
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Abstract
- Provide no more than a one-page research abstract briefly stating the problem, the research hypothesis, and the importance of the research.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients ≥ 18 years of age
- •subjects undergoing a liver biopsy for focal/diffuse abnormalities of the liver
- •parenchymal disease or chronically elevated liver function tests
- •for assessing degree of fibrosis in chronic liver diseases
- •or any indication deemed as necessary per the hepatologist/physician
排除标准
- •Coagulopathy (INR of ≥1.5 and/or platelet count ≤ 50,000)
- •Use of anticoagulants and/or blood thinners within 24 hours before the planned procedure
- •Liver lesions such as hemangioma, echinococcal cyst or vascular tumors,
- •Pregnancy,
- •Uncooperative patients
- •Any other condition or abnormalities that, in the opinion of the referring hepatologist or the advanced endoscopist, may compromise the safety of the patient or interfere with the patient participating in or completing the study.
结局指标
主要结局
portal tracts obtained
时间窗: 1 year
the number of complete portal tract obtained in a biopsy between EUS vs. the percutaneous approach.
次要结局
- Length of liver specimen.(1 year)
- Readmission rate related to the procedure(Investigators will follow up the patient in 1 week duration to note any adverse events/complication that might have caused patient to get admitted to the hospital)
- Number of needle passes needed to obtain adequate sample.(Investigators will follow up and obtain this information within 1 month after the procedure)
- Pain score(Score will be calculated subjectively at the time of discharge after the biopsy and again in 24-48 hours after the procedure)
- Details of the liver biopsy procedure(Investigators will follow up and obtain this information within 1 month after the procedure)
- Time for hospital stay per patient(Investigators will follow up and obtain this information within 1 month after the procedure)
- Opiates consumed (in milligrams) per patients(This will be recorded at the time of discharge after the biopsy and again in 24-48 hours after the procedure)
研究者
Ghassan M. Hammoud
Professor of Clinical Medicine
University of Missouri-Columbia