Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Score of quality of life
研究概览
简要总结
This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.
详细描述
There is no conflcts for treatment of symptomatic common bile duct stone. As more imaging examination such as healthy screening, more asymptomatic common bile duct stone patients are found. Current guideline for aymptomatic common bile duct stone is removal using endoscopic retrograde cholangiopancreatography. However, the previous studies that support this guideline included patients who just underwent cholecystectomy and were diagnosed as common bile duct stone. There is no prospective study for identify the treatment effectiveness of common bile duct stone removal in asymptomatic patients who are dignosed in healthy screening. Therefore, we are going to find the effectiveness of common bile duct stone removal by comparing questionnarie before and after removal of common bile duct stone in asymptomatic and incidentally found common bile duct stone patients. In addition, we are going to follow up patients who do not want to undergo common bile duct stone removal and find the rate of cholangitis risk. We also want to identify extact complication rate for endoscopic retrograde pancreatocholangiographic procedures in asymptomatic common bile duct stone.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed as common bile duct stone by image modality examination
- •agreement for this study enrollment
排除标准
- •no definite common bile duct stone by image modality examination
- •symptomatic patients who complain with fever/abdominal pain that compatible with common bile duct stone related symptom
- •previously diagnosed as pancreatobiliary malignancy
- •previously treated by endoscopic or percutaneous treatment for bile duct stones
- •severe cardio or pulmonary disease
- •pregnancy or possibility of pregnancy
- •who do not agree with study enrollment
结局指标
主要结局
Score of quality of life
时间窗: 3 months
Compare the quality of life before and after treatment
次要结局
未报告次要终点
研究者
Jun Heo
Assistant Professor
Kyungpook National University Hospital
