A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- need of switching to sphincterotomy
研究概览
简要总结
Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.
详细描述
Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.
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
- Double
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 undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis
排除标准
- •Consent not obtained.
- •No apparent stone.
- •Intradiverticular papilla.
- •Prior EST.
- •Bile duct stricture.
- •Pancreatic or biliary malignant disorders.
- •Intrahepatic stones.
- •Active acute pancreatitis.
- •Sphincter of Oddi dysfunction.
- •Pregnancy.
- •Primary sclerosing cholangitis or choledochocyst.
- •Previous biliary surgery other than cholecystectomy.
- •Stone impaction at ampulla.
- •Precut for cannulation.
结局指标
主要结局
need of switching to sphincterotomy
次要结局
- efficacy of lithotripsy
- post-ERCP complications