COMPARISON OF TISSUE QUALITY USING VARIOUS SUCTION TECHNIQUES IN ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY OF LYMPH NODES: A RANDOMISED STUDY
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the rate of histological adequacy in patients with lymph nodes who underwent EUS-FNB using 22-G FNB needles with the conventional stylet slow-pull or the wet aspiration with varying suction pressure.
研究概览
简要总结
Endoscopic ultrasound (EUS) guided fine needleaspiration (FNA) is a high-yielding and safe diagnostic modality for tissuediagnosis. Both lymph nodes and solid organs (pancreaticand extra-pancreatic) in the vicinity of the GI tract can be sampled withEUS-FNA. The key relevant outcomes for assessing any sampling technique include specimenadequacy, diagnostic yield, accuracy, and adverse events. In order to maximizethe quality and adequacy of the specimens using EUS-FNA, various techniqueshave been evaluated namely the use of different sampling techniques, number ofneedle passes, different needle sizes and designs, and lately, using acytopathologist for a rapid on-site evaluation. Majority of the studies have investigated theperformance of sampling techniques in solid lesions. But lymph nodes and solid lesions are entirely different interms of their structural histology and “tissue behaviorâ€. No study exists on the different suction techniques for only lymph nodes using the new generation of biopsy needles. Hence, this study was planned to evaluate the effect of the twotechniques of stylet slow-pull and wet suction with varying suction pressure onthe sample quality while carrying out EUS-FNB of lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- 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.age >18 years 2.lymph nodes visualized on EUS and amenable for biopsy 3.Informed consent to participate in the study.
排除标准
- •1.Age <18 years, 2.Lymph nodes inaccessible or not visualised with EUS 3.Lymph nodes <10 mm 4.international normalized ratio (INR) >1.5 5.platelet count of <50,000 cells/cubic millimetre 6.unstable clinical conditions or any contraindication for EUS 7.Inability to give informed consent 8.Pregnancy 9.Lesions returned to be not lymph nodes will be dropped out.
结局指标
主要结局
The primary endpoint will be the rate of histological adequacy in patients with lymph nodes who underwent EUS-FNB using 22-G FNB needles with the conventional stylet slow-pull or the wet aspiration with varying suction pressure.
时间窗: At baseline - during tissue acquisition
次要结局
- Specimen adequacy(At baseline - during tissue acquisition)
- Blood contamination of specimens(At baseline - during tissue acquisition)
- Comparison of the two techniques in terms of sensitivity, specificity, negative likelihood ratio, positive likelihood ratio & accuracy.(At baseline - during tissue acquisition)