19G FNB Vs 19G FNA-EUS guided liver biopsy- A non-inferiority randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- 1.Comparison of adequacy of liver biopsy specimen between 19 G EUS FNA and 19 G FNB needles with Pre processing length of longest piece more than 15 mm and CPTs more than or equal to 5 in number
研究概览
简要总结
Chronic liver disease can be due to various causes and usually diagnosed based on identification of risk factors and various blood tests. Identification of etiology becomes important as modification of risk factors and treatment of underlying cause of CLD can results in prevention of further liver damage and also reversal of underlying fibrosis or cirrhosis. There are various methods of liver biopsy with each modality has its merits and demerits. Previous studies have demonstrated that percutaneous, trans jugular and EUS guided liver biopsy were comparable in sample adequacy, but however, EUS liver biopsy was associated with lesser adverse events.In EUS guided liver biopsy previous studies have demonstrate that FNB needle gives larger samples than FNB but however, the histological diagnosis was comparable in both the groups. But, FNB needle costs around INR 40000 with one unit kit pricing around INR 63000 while FNA needle costs around 20000 with one EUS kit costing around 36000 making it more cost effective . In view of limited data comparing EUS LB using 19 G FNA versus 19 G FNB needles, we have planned this non inferiority randomized controlled trial comparing FNA vs FNB with 19 G needle taking primary objective as pre processing total sample length of atleast 15 mm and portal tracts of atleast 5 in number and histological diagnosis taking previously done studies as references.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients with an indication for liver biopsy 2.Platelet count more than 50,000 3.International normalized ratio (INR) less than 1.5.
排除标准
- •1.Age lessthan 18 years 2.Pregnant patients 3.Inability to obtain consent 4.Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7 to 10 days 5.Platelet count less than 50,000 6.INR morethan 1.5 7.Presence of ascites 8.Hemophilia.
结局指标
主要结局
1.Comparison of adequacy of liver biopsy specimen between 19 G EUS FNA and 19 G FNB needles with Pre processing length of longest piece more than 15 mm and CPTs more than or equal to 5 in number
时间窗: Baseline
2.Comparison of Diagnostic yield of liver biopsy between 19 G EUS FNA and 19 G FNB needles
时间窗: Baseline
次要结局
- 1.Length of Longest Piece(2.Number of Participants with LLP post-processing length less than 2 cm or more than 2 cm)
研究者
Ashish Agarwal
Department of Gastroenterology, AIIMS Jodhpur
