One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Recurrence of stones in the common bile duct
研究概览
简要总结
In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
详细描述
Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: 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, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.
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 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from the patient, child or legal representative
- •Age 0-80 years
- •Acute cholecystitis
- •Choledocholithiasis
- •Intraoperative ERCP
- •Preoperative ERCP followed by cholecystectomy
排除标准
- •Unwillingness or inability to consent to the study
- •Pregnancy
- •Age > 80 years
- •Previous ERCP or percutaneous transhepatic biliary drainage
- •Anastomosis in the upper gastrointestinal tract
- •Benign or malignant stricture
- •Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, other known cholestatic hepatopancreatobiliary disease, septic shock.
- •In combination with Mirizzi syndrome and intrahepatic bile duct stones
- •Congenital anomaly of the biliary tract
- •Malignant neoplasms
- •Acute pancreatitis
结局指标
主要结局
Recurrence of stones in the common bile duct
时间窗: 30 days after ERCP
The diagnosis of the stone in the common bile duct.
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 - success of the procedures as documented by a yes or no(1 month)
- Duration of the laparoscopic cholecystectomy,min(From enrollment to the end of treatment (3 month))
- Acute pancreatitis(within 14 days after ERCP)
- Duration of the Endoscopic retrograde cholangiopancreatography(From enrollment to the end of treatment (3 month))