A Prospective Randomized Study Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB) are well established techniques for the acquisition of tissue to classify a number of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic, lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available modality used to obtain cytological samples for analysis. The major shortcoming of this technique is the lack of a histological tissue core.
In recent years attention has turned to optimizing needle design to improve sample quality. New needles have been developed which aim to obtain a core of tissue with preserved architecture.
These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston Scientific, Marlborough, MA, United States).
Currently there are a paucity of studies comparing the performance of these needles, and only two of these are prospective randomized controlled trials. Real world performance of these needles has seldom been reported, with only one RCT including non-pancreatic masses in their analysis.
The investigators hypothesize that second generation needles have equivalent or better diagnostic performance than the prior first-generation needle.
To test this, the investigators aim to conduct a prospective randomized controlled study comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic, subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include a retrospective control arm of consecutive cases using the first-generation Reverse-bevel needle.
The investigatora aim to assess the diagnostic yield of each needle, as well as number of needle passes used, and specimen quality.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any solid tissue biopsy performed at the time of endoscopic ultrasound
排除标准
- •Fluid samples were excluded.
- •Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings
- •Cases where biopsy was deemed unsafe
结局指标
主要结局
Diagnostic yield
时间窗: At study completion, approximately 1 year after final subject enrolled
The percentage of lesions sampled for which a tissue diagnosis was obtained
次要结局
- Number of needle passes(At study completion, approximately 1 year after final subject enrolled)
- Sample bloodiness(At study completion, approximately 1 year after final subject enrolled)
- Target tissue cellularity(At study completion, approximately 1 year after final subject enrolled)
研究者
Alexander Huelsen
Gastroenterology Staff Specialist
Princess Alexandra Hospital, Brisbane, Australia