Study of the Patient Radiation Dose During Five Endourological Procedures

Not Applicable

Recruiting

• Conditions: Radiation Exposure; Urolithiasis
• Interventions: Radiation: frames per second

• Registration Number: NCT06384105
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-19
• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-22
• Last Update Submitted: 2024-04-22
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 870

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FPS >5-8	frames per second	Frames per second are set at \>5-8 at the beginning of the procedure
FPS 3-5	frames per second	Frames per second are set at 3-5 at the beginning of the procedure

Primary Outcome Measures

Name	Time	Method
Dose limit	1 year	Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL

Secondary Outcome Measures

Name	Time	Method
Difference in PRD	1 year	Difference in the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL when the FPS are set to 3 to 5 compared to \>5 to 8
PRD different centres	1 year	PRD differ between the different participating urologists and centres
PRD difference complicated cases	1 year	PRD difference between normal and complicated cases

Trial Locations

Locations (2)

UZA; 🇧🇪 Edegem, Antwerp, Belgium

AZ Klina; 🇧🇪 Brasschaat, Antwerp, Belgium