Randomized Clinical Trial Investigating the Best Method of Treatment of Common Bile Duct Stones
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of Adverse outcomes
研究概览
简要总结
ABSTRACT Introduction: Common bile duct (CBD) stone is a common clinical situation, especially in Asia area. Laparotomy and laparoscopic surgical procedure are often used for treatment. This study compares outcomes of different surgical procedures treating for the disease.
Methods/design: This is a prospective, randomized, controlled multicenter trial with three treatment arms. One group underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + intraoperative endoscopic nasobiliary drainage ENBD + primary closure of CBD. The other underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP) and subsequent LC and the third arm underwent laparoscopic cholecystectomy (LC) + laparoscopic CBD exploration (LCBDE) + primary closure of CBD. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
Discussion: Despite the fact plenty evidences provided by meta-analyses suggests that these approaches would appear comparable. It is hopeful to fully address which would be the better approach with this RCT 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with age between 18 - 80 years.
- •Patients diagnosed with gallstones.
- •Patients diagnosed with common bile duct stone by one of the three exam (US、MRCP and CT).
- •Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- •Patients understood the trial and accepted one of the three managements.
排除标准
- •Combined with Mirizzi syndrome and intrahepatic bile duct stones
- •Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD)
- •History of upper abdominal surgery.
- •Serious heart, brain, lung, metabolic diseases history.
- •Pregnant women.
- •Unwillingness or inability to consent for the study.
研究组 & 干预措施
Group A
干预措施: LC + LCBDE + ENBD + primary closure of CBD (Procedure)
Group B
干预措施: ERCP technique + LC (Procedure)
Group C
干预措施: LC + LCBDE + primary closure of CBD (Procedure)
结局指标
主要结局
Rate of Adverse outcomes
时间窗: 24 months
The patients developing complications/ the total patients
次要结局
未报告次要终点
研究者
Renyi Qin
Clinical professor
Tongji Hospital