Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Stone fragments clearance
研究概览
简要总结
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
详细描述
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ERCP common bile duct stone patients were able to provide written informed consent;
- •Size of stone large than 1.2 cm.
排除标准
- •Unwillingness or inability to consent for the study;
- •Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;
- •Previous ERCP;
- •Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy;
- •Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock;
- •Biliary-duodenal fistula confirmed during ERCP;
- •Pregnant women or breastfeeding;
- •Presence of intrahepatic duct stone;
- •Malignancy.
结局指标
主要结局
Stone fragments clearance
时间窗: 3 months
Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
次要结局
- Bleeding(3 months)
- Post-ERCP cholangitis(3 months)
- Perforation(3 months)
- Post-ERCP pancreatitis(3 months)
- The procedure time(3 months)