Nasobiliary Drainage After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing Postoperative Pancreatitis in Treating of Large Bile Duct Stones
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) has become one of the most important techniques in the treatment of bile duct stones. A number of studies have been conducted using large-balloon dilation (LBD) after adequate EST to extract large bile duct stones. In those studies, the authors suggested that EST plus LBD might lower the risk of post procedure pancreatitis (PEP) by directing balloon dilation toward the bile duct rather than the pancreatic duct. It has been reported that EPBD followed by insertion of nasobiliary drainage catheter can prevent PEP. However, it is still unclear that nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation for preventing postoperative pancreatitis in treating of large bile duct stones.The investigators therefore designed a prospective randomized trial to determine whether nasobiliary drainage prevent PEP after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
详细描述
Patients enrolled were confirmed the presence of CBD stones using magnetic resonance cholangiopancreatography. Patients with large bile duct stones were randomly assigned to EST+LBD+ENBD group and EST+LBD group. A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with visualized bile duct stones ≥12 mm in maximum transverse diameter. - Males and females, age > 18 years.
- •Normal amylase level before undergoing ERCP.
- •Signed inform consent form and agreed to follow-up on time.
排除标准
- •Bleeding diathesis
- •Prior EST or EPBD or ENBD
- •Billroth II or Roux-en-Y anatomy
- •Distal extrahepatic bile duct stenosis
- •Acute pancreatitis
- •Intrahepatic bile duct stones.
结局指标
主要结局
The prophylaxis effect of ENBD on post-ERCP pancreatitis after endoscopic sphincterotomy plus LBD for the treatment of large bile duct stones.
时间窗: the incidence of post-ERCP pancreatitis at 24 h after ERCP in two groups
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
次要结局
- Compare EST+LBD+ENBD group EST+LBD with group on the incidence of hyperamylasemia/adverse events.(the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups)