Study of the Patient Radiation Dose During Five Endourological Procedures

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06384105

Acronym

PRDE

Enrollment

870

Registered

2024-04-25

Start date

2023-12-19

Completion date

2024-12-18

Last updated

2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Exposure, Urolithiasis

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.

Interventions

RADIATIONframes per second

Other settings for frames per second

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Belgium

Contacts

Primary ContactVincent De Coninck, MD

vincent.de.coninck@klina.be+32 3 650 50 56

Backup ContactStefan De Wachter, MD

stefan.de.wachter@uza.be+32 3 821 33 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026