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临床试验/NCT03937037
NCT03937037已完成不适用

Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP

Hepatopancreatobiliary Surgery Institute of Gansu Province1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2019年5月10日最近更新:
适应症

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

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

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenbo Meng

M.D., Ph. D, Direct of surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (1)

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