EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease: A Randomized Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)
研究概览
简要总结
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance.
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.
详细描述
Aim and Objective - EUS-LB with a 19G Franseen needle is non-inferior to PC-LB with a 18G BioPince Needle, with regards to total specimen length and diagnostic adequacy.
Hypothesis - i. EUS-LB with a 19G FNB needle is non-inferior to PC-LB with a 18G full core biopsy needle, with regards to total specimen length and diagnostic adequacy.
ii. There would be lesser procedure related pain and higher patient satisfaction with EUS-LB compared to PC-LB.
Study population:
- Patients > 18 years of age.
- Eligibility for deep sedation with propofol.
- Undergoing liver biopsy for diagnosis/evaluation/staging.
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
- 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
- •Patients > 18 years of age.
- •Eligibility for deep sedation with propofol.
- •Undergoing liver biopsy for diagnosis/evaluation/staging.
排除标准
- •Coagulopathy, defined by platelet count < 70,000/mL and/or INR > 1.
- •Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure.
- •Presence of unrelieved biliary obstruction.
- •Presence of ascites.
- •Suspected or known hepatic malignancy.
- •Hypertensive patients with uncontrolled blood pressure. (SBP >150 and/or DBP>100mmHg)
- •Medically unfit for sedation.
- •Inability to provide informed consent.
- •Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
研究组 & 干预措施
Percutaneous Liver Biopsy
Procedure will be done by 18G BioPince Needle in percutaneous liver biopsy.
干预措施: Percutaneous Liver Biopsy (Diagnostic Test)
EUS Guided Liver Biopsy
Procedure will be done by 19G Franseen needle in EUS guided liver biopsy.
干预措施: EUS guided liver biopsy (Diagnostic Test)
结局指标
主要结局
Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)
时间窗: Day 0
次要结局
- Proportion of specimens >20mm in aggregate length.(3 days)
- Total number of fragments.(Day 0)
- Pre-fix aggregate specimen length.(3 days)
- Proportion of specimens with >11 CPTs.(3 days)
- Total Number of fragments >9mm.(3 days)
- Proportion of specimens with a conclusive etiological diagnosis(3 days)
- Post-procedure pain measured on Visual Analogue Scale from (Minimum: 0, Max:10)(4 hours)
- Pre-fix longest intact specimen length.(3 days)
- Total specimen complete portal tracts (CPTs).(3 days)
- Adverse events after the procedure(72 hours)
- Proportion of specimens with a conclusive pathological diagnosis(3 days)