Prospective Multicentric Study of the Patient Radiation Dose During Five Endourological Procedures: Insertion and Replacement of Ureteral Stent, URS, (Mini-)PCNL/ PCNL and ESWL/SWL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 870
- 试验地点
- 4
- 主要终点
- Dose limit
研究概览
简要总结
In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.
Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients who receive insertion/replacement of ureteral stent, URS (flexible or semirigid), (mini-)PCNL (including ECIRS) or ESWL under fluoroscopic with or without ultrasonic guidance
- •Only cases performed or directly supervised by experts
排除标准
- •Bilateral cases
- •Diagnostic ureterorenoscopies
- •Antegrade ureteroscopies
- •Procedures for Upper Tract Urothelial Carcinoma (UTUC)
- •Procedures on children (aged <18 years)
- •Pregnant women
- •Abnormal urinary anatomy (e.g. ureteral duplication, pelvic kidney, bladder derivation, horseshoe kidney)
结局指标
主要结局
Dose limit
时间窗: 1 year
Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL
次要结局
- Difference in PRD(1 year)
- PRD different centres(1 year)
- PRD difference complicated cases(1 year)
研究者
Vincent De Coninck
Principal Investigator
Universiteit Antwerpen