Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones-a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- stone clearance rate at the index session
研究概览
简要总结
To compare the technique of combined balloon sphincter dilation after an initial sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct stones. The investigators hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.
详细描述
Endoscopic sphincterotomy is a standard technique to enlarge the bile duct opening before stone removal during endoscopic retrograde cholangiopancreatography. However, complete sphincter ablation by endoscopic sphincterotomy is not always possible. Also, due to the tapering end of the distal duct, standard sphincterotomy may not be adequate for removal of particularly large stones. In a retrospective series by Ersoz et al, the addition of balloon dilation after sphincterotomy achieves a high stone clearance rate (89-95%). The investigators postulate that the combination of endoscopic sphincterotomy followed by balloon dilation may allow easier stone retrieval with acceptable complication rate.
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
- Triple (Participant, Investigator, 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
- •Patients at least 18 years old, presented to Prince of Wales Hospital for endoscopic retrograde cholangiopancreatography (ERCP) for known or suspected bile duct stones are invited to participate.
- •Informed consent will be obtained before the beginning of ERCP.
- •Patients are randomized to EST or ESBD after confirming the presence of bile duct stones on the initial cholangiogram
排除标准
- •septic shock, coagulopathy (international normalized ratio >1.3,
- •partial thromboplastin time greater than twice that of control),
- •platelet count <50,000x103/uL or
- •ampullary tumors
研究组 & 干预措施
Standard sphincterotomy (ES)
After deep cannulation, a pull-type sphincterotomy will be performed with a 25mm sphincterotome (eg clever cut, Olympus, Tokyo, Japan) with division of sphincter up to the duodenal wall. A complete sphincterotomy is defined by the free passage of a fully bowed sphincterotome with a 25m wire and spontaneous bile drainage.
干预措施: Standard sphincterotomy (Procedure)
Sphincterotomy plus balloon dilation (ESBD)
After complete sphincterotomy, a 3-cm long 15mm diameter CRE balloon is passed over a guidewire across the lower end of common bile duct. The contrast filled balloon is inflated to the size of the bile duct for around 30 seconds until waisting is abolished.
干预措施: endoscopic balloon dilatation (Procedure)
结局指标
主要结局
stone clearance rate at the index session
时间窗: 24 hours
The ability to achieve complete stone clearance on the first ERCP
次要结局
- Number of ERCP's required to achieve stone clearance(3 months)
- ERCP related complications(30 days)