Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- post ERCP pancreatitis
研究概览
简要总结
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
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
- Single (Participant)
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
- •older than 18 years of age -
排除标准
- •if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy
研究组 & 干预措施
Standard Cannulation
Standard Biliary Cannulation
干预措施: standard biliary cannulation (Procedure)
NKF Cannulation
Biliary Cannulation using NKF technique
干预措施: Needle Knife Fistulotomy (Procedure)
结局指标
主要结局
post ERCP pancreatitis
时间窗: within 48 hours of the procedure
Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure
次要结局
- Perforation(within 48 hours)
- Bleeding(within 48 hours)