跳至主要内容
临床试验/NCT07009587
NCT07009587已完成不适用

Ionizing Radiation During Endoscopic Procedures: a Single-center, Prospective Study of Dose Reference Levels.

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 2,782 人开始时间: 2018年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,782
试验地点
1
主要终点
dose reference level

研究概览

简要总结

The primary objective of this prospective study was to describe the evolution of dose reference levels (DRLs) in a specialized French center during endoscopic procedures involving ionizing radiation and performed without a radiology technician. The secondary objective was to assess the influence of the operator on the recorded dose for each procedure.

详细描述

This prospective study, approved by the Institutional Review Board (IRB) of the Groupement de Coopération Sanitaire Ramsay Santé (approval no. 2019-06-010), was conducted in the endoscopy unit of Jean Mermoz Hospital (Lyon, France).

To standardize practices, all operators underwent blended training (3 hours of e-learning and 3 hours of hands-on training on the Shine Enhancer system), which was completed and validated on June 25, 2018. As per guidelines, the graphic (cine) mode was never used. Only the latest fluoroscopic images were printed and archived.

The database includes all consecutive patients who underwent an endoscopic procedure between June 26, 2018, and December 31, 2021. Each report was retrospectively reviewed to confirm the therapeutic intention (intention-to-treat).

Initially, only the type of procedure and the dose-area product (DAP) were recorded. From October 7, 2019, fluoroscopy time (FT) was also systematically collected.

Six experienced endoscopists performed all procedures. The patient's position varied depending on the procedure, although most were performed in the supine position under general anesthesia. No radiologic technician was present during the procedures. The fluoroscopic system was entirely managed by the endoscopist, including all parameter adjustments (distance between patient and detector, use of pulsed vs continuous fluoroscopy, collimation, duration, etc.).

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

入选标准

  • Patients aged 18 years or older, who have been informed of the research;
  • Patients who have undergone an endoscopic procedure under radiological control
  • Subjects for whom all data concerning the methods of exposure to ionizing radiation are available;

排除标准

  • Patient under legal protection, guardianship, or curatorship;
  • Patient who has indicated their opposition to the use of their medical data (by completing and returning the opposition form that will be sent to them).

结局指标

主要结局

dose reference level

时间窗: Periprocedural

Assessment of dose reference levels (DRLs) with the Dose Area Product (DAP) collected for each procedure

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Ionizing Radiation During Endoscopic Procedures... | 临床试验