Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Success rate of selective cannulation by trainee
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform enough cases to grasp this technique. The methods of ERCP training include hands-on teaching, training on different kinds of simulators, training on ex-vivo or live anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.
Selective cannulation is considered the most difficult and challenging part of learning ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP training. The time used for attempting cannulation by trainees was 5min or 10min in several centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major complication related to cannulation, was 4.0%, which was comparable with previous studies.
The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation would increase success rate of selective cannulation and help to improve skills more quickly. At the meantime, with actively verbal or hands-on assistance from the instructor during performance of trainees, the risk of complications would not increased with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study was designed to evaluate the effects of different periods of time for trainees to attempt selective cannulation on success rate of cannulation, self-satisfaction of performance and post-ERCP pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age 18-90 years old;
- •Without prior EST.
排除标准
- •History of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
- •Duodenal stricture (benign or malignant);
- •Ampullary carcinoma;
- •Previously failed selective cannulation;
- •Chronic pancreatitis with PD stone;
- •Minor papilla cannulation;
- •Papilla fistula;
- •Severe diseases of heart, lung, brain and kidney;
- •Hemodynamical unstability;
- •Pregnant women;
- •Refusal or unable to give written informed consent.
结局指标
主要结局
Success rate of selective cannulation by trainee
时间窗: up to one year
The rate of successful selective cannulation by trainee in one year.
次要结局
- Complication rate(up to one year)
- Performance score of selective cannulation by trainees(up to one year)
- Difficulty score of cannulation(up to one year)
- Final success rate of cannulation(up to one year)
- Total time of successful cannulation(up to one year)
- Rate of Needle-knife precut sphincterotomy(up to one year)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China