NCT03074201已完成不适用
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Stone clearance
研究概览
简要总结
Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age 18 and above
- •Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
- •Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Participation in another related investigational study that could affect the results of this study within the previous 30 days
- •Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
- •Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)
- •Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
研究组 & 干预措施
Cholangioscopy
Experimental
Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy
干预措施: Cholangioscopy (Procedure)
Cholangioscopy
Experimental
Participants in this arm undergo radiation-free ERCP facilitated by cholangioscopy
干预措施: Spyglass DS Cholangioscope (Device)
结局指标
主要结局
Stone clearance
时间窗: During the cholangioscopy procedure
Successful clearance of stones from the bile duct using cholangioscopy
次要结局
- Procedure Duration(5 minutes to 2.5 hours anticipated time frame)
研究者
Subhas Banerjee
Associate Professor of Medicine
Stanford University
研究点 (2)
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