ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy for Cholecystocholedocholithiasis - The Same Operator: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- success rate
研究概览
简要总结
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
详细描述
Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.
Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.
Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with cholecystocholedocholithiasis
- •American Society of Anesthesiologists (ASA) scores of I-III
- •Age 20-70 years.
排除标准
- •cholangitis,
- •acute biliary pancreatitis,
- •suspected Mirizzi syndrome,
- •suspected hepatobiliary malignancy,
- •perforated gallbladder,
- •biliary peritonitis,
- •intrahepatic stones,
- •previous cholecystectomy,
- •altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
- •Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.
结局指标
主要结局
success rate
时间窗: 2 years
successful laparoscopic cholecystectomy and successful common bile duct stone extraction
次要结局
- The total cost of treatment(30 days)
- mortality(3 years)
- Hospital stay(30 days)
- operative time(from 1 to 5 hours)
- morbidity(3 years)
- the number of hospital readmission(3 years)
- the number of postoperative intervention(3 years)
研究者
Mohammed Ahmed Omar, MD
Associate professor of surgery
South Valley University