A Prospective Interventional Pilot study evaluating the Safety and Efficacy of EndoscopicUltrasound guided Liver Biopsy in coagulopathy patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary Outcomes;
研究概览
简要总结
Although various noninvasive markers are emerging, liver biopsy plays an important role
in the diagnosis, prognosis and therapeutic decision in various liver diseases. Various
routes for liver biopsy include percutaneous (PC), trans-jugular (TJ) and surgical.
Percutaneous liver biopsy is associated with complications like pain, life threatening
bleeding etc. By 1970s, trans-jugular liver biopsy emerged to overcome the
contraindications like coagulopathy and ascites of percutaneous route.
Introduction of Endoscopic ultrasound has changed the investigation and management
of gastric, pancreatic and hepatobiliary diseases. First case report of Endoscopic
Ultrasound guided liver biopsy was published in 2007. Since then various authors have
published case series in the last decade.
The PC and TJ methods have limited access to sample different areas of the liver, the EUS
method allows greater access to both hepatic lobes, increasing the adequacy and yield
of tissue. The EUS-LB provides clinicians with a real-time, detailed view of the biopsy
needle through the course of the liver and the trajectory can be changed if needed as
part of the “fanning†technique to get a more representative sample. Multicenter
experience published by Diehl et al. (2015) showed that EUS liver biopsy have a high
safety profile and yield comparable to percutaneous route. In a retrospective analysis
Pineda et al (2016) have shown that EUS liver biopsy have significantly high yield as
compared to both percutaneous as well as trans-jugular route.
Previous studies have used either Tru-cut needle or FNA needle for liver Biopsy. In this
prospective study, our aim is to assess the safety and efficacy of EUS guided liver biopsy
using a 19-gauge FNB (fine needle biopsy) needle in coagulopathy patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult Patients (Age>18 years) where liver biopsy is indicated 2.Those having coagulopathy or thrombocytopenia Coagulopathy is defined as INR>1.5 Thrombocytopenia is defined as Platelet count less than 1 lac/mm3.
排除标准
- •1.Age<18 years 2.Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only) 3.Inability to obtain Consent 4.Patient with INR >2.5 5.Patient with Platelet count below 30000/mm3
- •Patients with known malignancy precluding liver biopsy 7.Patient with Sepsis 8.Patient diagnosed with Acute liver Failure 9.Patient with diagnosis of Obstructive Jaundice 10.Patient on Anticoagulation.
结局指标
主要结局
Primary Outcomes;
时间窗: 1 year
â— Specimen quality for histological diagnosis in coagulopathy patient
时间窗: 1 year
be made based on the amount of tissue obtained in needle.
时间窗: 1 year
â— Specimen quality for histological diagnosis: Defined as histological diagnosis could
时间窗: 1 year
â— Portal Tract number: number of Complete Portal Tracts (CPTs)
时间窗: 1 year
â— Specimen length: Total Sample Length (TSL) and Longest sample Length (LSL)
时间窗: 1 year
次要结局
- Adverse events;(1.Bleeding-not requiring blood transfusion)