NCT01711294已完成不适用
A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
研究概览
简要总结
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
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
- •Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
- •Indicated for EUS evaluation of the PCL including EUS-FNA.
- •Age 18 years of age or older.
- •Willing and able to comply with the study procedures and provide written informed consent form to participate in the study.
排除标准
- •Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to the cyst.
- •Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines.
- •Standard contraindications for EUS.
- •Known pancreatic pseudocyst.
- •Pregnancy.
结局指标
主要结局
Volume of Aspirated Cyst Fluid as a Function of Estimated Maximal Volume
时间窗: At procedure (Up to 1 hour)
Volume of aspirated cyst fluid as a function of estimated maximal volume, based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume)
次要结局
- Change in Volume of Cyst Post Initial Procedure Compared to Pre Procedure(Procedure (Up to 1 hour))
- Number of Participants With Successful Echoendoscopic Fine Needle Aspiration of PCL(Procedure (up to 1 hour))
- Number of EUS-FNA Needle Passes at Initial Procedure.(Procedure (Up to 1 hour))
- Number of Needles With Needle Removal Rated as Excellent/Very Good(Procedure (Up to 1 hour))
- Number of Needles With Needle Visualization Rated as Excellent/Very Good(Procedure (Up to 1 hour))
- Number of Patients With Related Adverse Events(30 days)
- Number of Participants With PCL Reached/Penetrated(Procedure (Up to 1 hour))
- Number of EUS-FNA Needles Used at Initial Procedure.(Procedure (Up to 1 hour))
- Number of Needles With Needle Insertion Rated as Excellent/Very Good(Procedure (Up to 1 hour))
- Rate of Cross-over to Salvage Arm(Procedure (Immediate))
- Number of Participants Requiring Post EUS-FNA Patient Management(30 days)
- Number of Participants Whose Management Decision Was Directly Influenced by the EUS Findings(Procedure - 30 days after procedure)
- Time Needed for Aspiration for Each Needle Pass at Initial Procedure.(Procedure (Up to 1 hour))
- Time From First Needle Pass in to Last Needle Pass Out at Initial Procedure.(Procedure (Up to 1 hour))
- Number of Participants With Accurate Diagnosis of the Disease State Using the EUS-FNA Needles(up to 2 years)
研究者
研究点 (14)
Loading locations...
相似试验
Unknown
不适用
Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic MassesPancreatic TumorNCT01978808National Taiwan University Hospital200
已完成
1 期
Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic MalignancyPancreatic CancerNCT03016637Odense University Hospital40
Unknown
不适用
Diagnostic Accuracy of FNA: is Aspiration- Related?PANCREATIC CANCERNCT01717196The Mediterranean Institute for Transplantation and Advanced Specialized Therapies100
Unknown
不适用
Comparison of EUS-Guided Fine Needle Aspiration TechniqueEUS-FNACytodiagnosisNCT01923883Asan Medical Center51
撤回
不适用
Comparison Study in Pancreatic Fiducial PlacementPancreatic NeoplasmsNCT02376543Parkview Health