A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- Perioperative Complication Rate
研究概览
简要总结
The incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations
- •Age <80y and >18y
- •Non-emergency surgery
排除标准
- •Diagnosis of Mirizzi's syndrome,
- •Acute suppurative cholangitis
- •Detection of bilioenteric anastomosis
- •Pathological diagnosis of cholangiocarcinoma
- •Extended surgery due to multiple biliary strictures,
- •Intrahepatic stones
结局指标
主要结局
Perioperative Complication Rate
时间窗: 1 month after surgery
次要结局
未报告次要终点
