Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 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 a technically challenging procedure. It takes time to learn the basic skills and need at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. Traditional hands-on ERCP training requires the trainer to be on-site to assist the trainee with ERCP operations. We hypothesized that the trainee can be safely guided by trainer off-site with interactive audio and endoscopic and fluoroscopic view. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. Teleguidance facilitated ERCP cannulation is a strategy to provide expert cannulation guidance to trainee in settings where such expertise is not on-site. Teleguidance not only reduces unnecessary radiation exposure of endoscopist, but also provides remote assistance for trainees to complete training or further improve skills. Given the advantages of the off-site teleguidance, it could be an attractive substitute for on-site hands-on ERCP training.
The primary aim of this study was to evaluate whether off-site assistance (Off group) could achieve a comparable success rate to on-site assistance (On group) regarding the rates of successful selective biliary cannulation during ERCP training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (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
- 是
入选标准
- •Age 18-90 years old
- •With native papilla
排除标准
- •History of partial or total gastrectomy (Billroth I/II, Roux-en-Y)
- •Type II duodenal stenosis
- •Previously failed cannulation
- •Chronic pancreatitis with stones in the pancreatic head
- •Hemodynamic instability
- •Lactating or pregnant women
- •Inability 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 during the training period.
次要结局
- Final success rate of cannulation(up to one year)
- Total time of successful cannulation(up to one year)
- Performance score of selective cannulation(up to one year)
- Radiation exposure time(up to one year)
- Complication rate(up to one year)
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China