NCT02022605暂停不适用
Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Success rate of selective cannulation in 10min by trainee
研究概览
简要总结
Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •consecutive inpatients with naive papilla undergoing ERCP.
排除标准
- •history of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
- •duodenal stricture (benign or melignant);
- •ampullary carcinoma;
- •previously failed selective cannulation;
- •chronic pancreatitis with PD stone;
- •minor papilla cannulation;
- •servere diseases of heart, lung, brain and kidney;
- •hemodynamical unstablility;
- •pregnant women;
- •refusal or unable to give written informed consent.
研究组 & 干预措施
Hands-on EMS training group
Experimental
干预措施: Hands-on EMS training (Device)
Hands-on EMS training group
Experimental
干预措施: Standard training (Other)
Standard training group
Active Comparator
干预措施: Standard training (Other)
结局指标
主要结局
Success rate of selective cannulation in 10min by trainee
时间窗: 2 years
次要结局
- Performance score of selective cannulation(2 years)
- Total time of successful cannulation(2 years)
- Cumulative success rate of each month(2 years)
- Performance score of EST(2 years)
- Complication rate(2 years)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China
研究点 (1)
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