Comparison Study in Pancreatic Fiducial Placement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Total Cost Comparison
研究概览
简要总结
Comparison Study between 19 gauge EUS FNA BNX Needle vs. 22 gauge EUS FNA BNX Needle in Pancreatic Fiducial Placement To Treat Pancreatic Cancer
详细描述
A prospective multicenter study to compare the cost, time, complications, and migrations rate of two commercially available FDA approved needles; 19 gauge endoscopic ultrasound (EUS) fine needle aspiration (FNA) BNX needles to 22 gauge EUS FNA BNX needles.
There will be fiducials placed in the pancreas according to facility policy and procedure.
This is a randomized prospective multicenter trial. A minimum of 14 patients and a maximum of 30 patients will be enrolled at up to ten participating sites. Enrollment is projected to be complete within approximately one year.
Adult subjects with a diagnosis of pancreatic cancer who will receive SBRT for pancreatic cancer via Cyberknife or Tomotherapy will undergo EUS guided fiducial marker placement.
Subjects will be randomized to receive fiducial marker placement with either a 19 gauge EUS, FNA BNX needle or a 22 gauge EUS, FNA BNX needle. For all patients, standard hospital protocol will be followed for EUS procedures and patient care management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects that plan to undergo CyberKnife treatment for pancreatic cancer
- •Subjects that are deemed physically able to undergo anesthesia (either Monitored Anesthesia Care (MAC) or general anesthesia)
- •Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent
- •Subjects 18 years of age or older
- •Subject must be able to hold anticoagulants as per institutional standard of care
- •Women of child bearing potential who are not pregnant as proven by a negative pregnancy test
排除标准
- •Subjects that are unable to tolerate anesthesia for the procedure
- •Subjects 17 or under
- •Subjects that refuse treatment for pancreatic cancer d Subjects whose anticoagulants cannot be held
- •e. Subjects who have distant metastatic disease f. Subjects who cannot or refuse EUS guided procedures. g Subjects who are pregnant
研究组 & 干预措施
19 Gauge EUS FNA BNX
Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 19 gauge technique (ARM 1) of EUS guided fiducial marker technique.
干预措施: 19 Gauge EUS FNA BNX (Device)
22 Gauge EUS FNA BNX
Subjects receiving EUS and fluoroscopic guidance for placement of fiducial markers into the pancreas will have the 22 gauge technique (ARM 2) of EUS guided fiducial marker technique.
干预措施: 22 Gauge EUS FNA BNX (Device)
结局指标
主要结局
Total Cost Comparison
时间窗: Duration of Fiducial Placement Procedure; approx 30 minutes
Total cost of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment of pancreatic cancer.
Total Time Comparison
时间窗: Duration of fiducial placement procedure; up to 30 minutes
Time comparison of EUS guided fiducial placement in the pancreas to facilitate SBRT treatment
次要结局
- Migration Comparison(Duration of SBRT treatment; up to 8 weeks.)
- Complication Comparison(Duration of SBRT treatment; Up to 8 weeks)
研究者
Neil Sharma, M.D.
Interventional Gastroenterologist
Parkview Health