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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 870
- Locations
- 4
- Primary Endpoint
- Dose limit
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Dose limit
Time Frame: 1 year
Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL
Secondary Outcomes
- Difference in PRD(1 year)
- PRD different centres(1 year)
- PRD difference complicated cases(1 year)
Investigators
Vincent De Coninck
Principal Investigator
Universiteit Antwerpen