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临床试验/NCT06197815
NCT06197815招募中不适用

Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study

Air Force Military Medical University, China3 个研究点 分布在 1 个国家目标入组 754 人开始时间: 2020年12月3日最近更新:
适应症

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

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

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Professor

Air Force Military Medical University, China

研究点 (3)

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