Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Number of Participants with Recurrence of CBD Stones
研究概览
简要总结
In this prospective study, the investigators assessed the utility of intermittent saline irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic extraction for common bile duct stones, and it does not increase the rate of procedure-related complications.
详细描述
In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.
The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •With ERCP indications
- •With mechanical lithotripsy during operation
排除标准
- •Unwillingness or inability to consent for the study
- •Unstable vital signs
- •Coagulation dysfunction (INR>1.5) and low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- •Prior surgery of Bismuth Ⅱ, Roux-en-Y and cholangiojejunostomy
- •Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, 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
结局指标
主要结局
Number of Participants with Recurrence of CBD Stones
时间窗: 3 years
Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
次要结局
- Number of Participants with Cholangitis(3 years)
- Number of Participants with Bleeding(1 month)
- Number of Participants with Pancreatitis(3 years)
- Procedure time of each case(7 days)
- Number of Participants with Perforation(1 month)
研究者
Wenbo Meng
M.D., Ph. D, Direct of surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province
