Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 754
- 试验地点
- 3
- 主要终点
- Rates of successful biliary cannulation
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. It required the trainer to stand by the trainee in the procedure room to assist. There were insufficient patients for most trainees to achieve competence until the trainee graduate. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. We hypothesized that the trainee can be safely guided by a senior trainer off-site with the endoscopic view displayed on a screen. Using the teleguidance, the trainer can even continue to provide guidance when the trainees complete their training and return to their hospitals until they achieve the recommended clinical competency. Given the advantages of the off-site teleguidance, it could be an attractive substitute for hands-on assistance to ERCP training.
The primary aim of this study was to evaluate whether off-site assistance (OA group) could achieve a comparable success rate to standard hands-on assistance (HA group) with regard to 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
- Other
- 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
- 是
入选标准
- •Patients aged 18-90 years who received ERCP
- •Patients with native papilla
排除标准
- •Patients with altered anatomy (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
Rates of successful biliary cannulation
时间窗: 10 minutes
The percentage of trainee successfully biliary cannulation
次要结局
- Competency score from the trainer and endoscopic video(1 day)
- Incidences of PEP and other adverse events(1 month)
- Ionizing radiation time(1 day)
- Cannulation time(1 day)
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China
