Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
试验速览
- 阶段
- 不适用
- 入组人数
- 2,700
- 试验地点
- 1
- 主要终点
- Rate of Adverse outcomes
研究概览
简要总结
Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 (MRI、MRCP and CT).
- •Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration.
- •Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE).
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.
结局指标
主要结局
Rate of Adverse outcomes
时间窗: 3 years
The patients with complication / the total patients
次要结局
- Hospital stay(3 years)
- Stricture of the bile duct rate rate(3 years)
- Operation time(3 years)
- Bile leakage rate(30 days)
- Mortality(3 years)
- Perforation Rate(30 days)
- Acute cholangitis rate(30 days)
- Hemorrhage Rate(3 years)
- Acute pancreatitis Rate(30 days)
- Incremental cost-effectiveness ratio(3 years)
研究者
Zhongtao Zhang
Doctor
Beijing Friendship Hospital