Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone in a Group of High and Low Risk of Pep, Submitted to Pep Prophylaxis
试验速览
- 阶段
- 不适用
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)
详细描述
- Introduction
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced procedure which is widely used in the diagnosis and treatment of a variety of benign and malignant pancreatobiliary disorders1,2,3,4,5.
Selective cannulation of the common bile duct (CBD) is the most important and challenging step in a biliary endoscopic retrograde cholangiopancreatography6,7. However, in the first ERCP, even in experienced hands, biliary cannulation may fail in up to 15 % - 35 % of cases when using standard methods alone8. In this subset of patients, additional cannulation techniques are needed to access the CBD in order to continue with the ERCP.
Precut is the most common strategy used by experienced endoscopists, when conventional methods have failed7. Needle knife fistulotomy (NKF) and conventional precut are the two most common variants. Recently published guidelines recommend opting for NKF, as evidence suggests a lower risk of adverse events, especially pancreatitis, when used early in the biliary cannulation algorithm7,9.
Technically NKF is the creation of an artificial fistula between the most protuberant portion of the papilla, which represents the intraduodenal portion of the CBD and the biliary tract by using a diathermic cutter of the needle type6,10,11,12,13,14,15,16,17,18. Its big advantage over conventional precut is that it avoids the contact of the cutting device with the papillary orifice and therefore avoiding direct thermal injury to the pancreatic duct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •ERCP with indication for biliary access
- •Naïve papilla
排除标准
- •Flat papillas
- •Intradiverticular / Diverticular border papillas
- •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
Technical success
时间窗: 1 day (same day of the procedure)
Comparison of technical success between the two strategies
Adverse events
时间窗: 30 days from the procedure
Comparison of adverse event rate between the two strategies
次要结局
- Technical success among sub groups(1 day (same day of the procedure))
- Adverse event rate among sub groups(30 days from the procedure)
研究者
Luis Lopes
Assistant Professor (MD, PhD, MBA)
University of Minho
