Prospective Evaluation of the Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) Guided Cholangiopancreatoscopy With the SpyGlass DS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Number of Participants With Procedure Technical Success
研究概览
简要总结
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.
详细描述
Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care
排除标准
- •failure to provide informed consent
- •any contraindications to endoscopy
结局指标
主要结局
Number of Participants With Procedure Technical Success
时间窗: Day 1
The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.
次要结局
- Measurement of Total Procedure Time Using the Spyglass DS(approximately 2 hours)
- Measurement in Minutes for Spyglass DS Diagnostic Maneuvers(approximately 2 hours)
- Number of Participants With Successful Removal of the Biliary or Pancreas Stones(Day 1)
- Measurement in Minutes for Spyglass DS Therapeutic Maneuvers(approximately 2 hours)
- Time to Set-up the Spyglass DS for the Procedure(approximately 2 hours)
- Number of Cholangioscopic Exams That Detected Ductal Stones(Day 1)
- Strictures Found During the Procedure Will be Measured(Day 1)
- Spybite Sampling Attempts Per Procedure(Day 1)