跳至主要内容
临床试验/NCT04341909
NCT04341909已完成不适用

Trainee Involvement in ERCP Risk Score

Clinical Hospital Colentina1 个研究点 分布在 1 个国家目标入组 1,283 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,283
试验地点
1
主要终点
any procedure related adverse outcome

研究概览

简要总结

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

详细描述

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.

Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.

data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.

Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients undergoing ERCP in the participating centers
  • •informed consent signed prior to the procedure

排除标准

  • •refusal to participate / sign the informed consent

结局指标

主要结局

any procedure related adverse outcome

时间窗: 30 days

including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis

次要结局

未报告次要终点

研究者

发起方
Clinical Hospital Colentina
申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Theodor Alexandru Voiosu

MD, PhD

Clinical Hospital Colentina

研究点 (1)

Loading locations...

相似试验