NCT01708109终止不适用
Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 18
- 主要终点
- Natural process of biliary calculus left after cholecystectomy
研究概览
简要总结
The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •cholecystectomy
排除标准
- •Ongoing icterus or pancreatitis
- •History of anamneses pancreatitis/icterus
- •Allergy against x-ray contrast
- •Stones more than 6 mm in ductus
- •No passage of contrast to duodenum
- •malignant
结局指标
主要结局
Natural process of biliary calculus left after cholecystectomy
时间窗: 12 month post op
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed
次要结局
- Complications biliary calculus(12 month post op)
研究者
Anders Thorell
Ass. Prof.
Karolinska Institutet
研究点 (18)
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