Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Recurrence of common bile duct stones
研究概览
简要总结
Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC after ERCP. Given the inflammation of the gallbladder and the inflammatory process in the hepatoduodenal ligament, early laparoscopic cholecystectomy can lead to various intraoperative complications. The aim of this retrospective study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).
详细描述
There is no gold standard for the treatment of cholecystocholedocholithiasis in the pediatric population. The most common method for resolving biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). There are different approaches to the treatment of cholecystocholedocholithiasis: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and LC after ERCP. Both LCBDE and LERV allow for the simultaneous treatment of cholecystocholedocholithiasis. However, many medical institutions do not have the opportunity to use these methods due to the difficulties of implementation and the need for specialized training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis remains a subject of debate. The present study aims to compare ERCP with ES + delayed LC in intra- and re-hospitalization in pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from child or legal guardian
- •Age 0-18 years
- •Acute cholecystitis
- •Choledocholithiasis
排除标准
- •Unwillingness or inability to consent to the study
- •Previous ERCP or percutaneous transhepatic biliary drainage
- •Benign or malignant stricture
- •Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, septic shock.
- •In combination with Mirizzi syndrome and intrahepatic bile duct stones
- •Congenital anomaly of the biliary tract
- •Malignant neoplasms
- •Acute pancreatitis before the procedure
结局指标
主要结局
Recurrence of common bile duct stones
时间窗: 60 days after ERCP
The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy.
次要结局
- Bleeding(30 days after ERCP)
- Perforation(30 days after ERCP)
- Bile leak(30 days after ERCP)
- Acute cholangitis(60 days after ERCP)
- Bile duct stricture(1 year after ERCP)
- Time spent in hospital until discharge(from admission to hospital until the end of treatment (up to 8 weeks))
- Technical success(1 month)
- Acute pancreatitis(30 days after ERCP)
- Duration of the laparoscopic cholecystectomy,min(From enrollment to the end of treatment (3 month))
- Duration of the Endoscopic retrograde cholangiopancreatography,min(From enrollment to the end of treatment (3 month))