PRIMARY NEEDLE KNIFE FISTULOTOMY FOR BILIARY CANNULATION IN A CONSECUTIVE GROUP OF PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Evaluate the outcomes of NKF as an initial method for biliary access.
详细描述
Introduction
A previous feasibility study has suggested that needle knife fistulotomy (NFK) as an initial method for biliary access in patients with stones is associated with high levels of success and low rate of complications. This study evaluated the outcomes of NKF as an initial method for biliary access, in a large number of patients with any type of biliary pathology (tumors and stones), on the basis of success rate, complications and factors associated with success and complications.
Financial resources
All participants included in this study will perform ERCP, laboratory tests and other complementary diagnostic tests after a duly justified medical prescription. Therefore there are no additional costs or consumption of hospital resources.
Ethical considerations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ERCP with indication for biliary access
- •Naïve papilla
排除标准
- •Patients unable to sign or understand the informed consent
- •Patients with surgically altered anatomy
- •Patients with tumors of the papilla
- •Previous sphincterotomy
- •Spontaneous papillary fistula
- •Papilla not visualized
结局指标
主要结局
Adverse events
时间窗: 30 days from the procedure
Comparison of adverse event rate between the two strategies
Technical success
时间窗: 1 day (same day of the procedure)
Comparison of technical success between the two strategies
次要结局
未报告次要终点