A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete clearance of CBD stones
- •No definite GB stones
- •Agree with the study protocol
排除标准
- •< 18 years of age
- •Concomitant IHD stones
- •Combined malignancy with a limted life span
- •Prior cholecystectomy state
- •refusal to agree to the study protocol
结局指标
主要结局
Complications
时间窗: two year
The primary outcome is biliary complications between two groups during follow-up.
次要结局
- Natural outcomes(two year)
- Other adverse events(two year)
研究者
Tae Hoon Lee
Principal Investigator
Soon Chun Hyang University