Study of the Patient Radiation Dose During Five Endourological Procedures

Urolithiasis Clinical Trial

— PRDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384105
• Other study ID #: PRDE1
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: December 18, 2024

Study information

• Verified date: April 2024
• Source: Universiteit Antwerpen
• Contact: Vincent De Coninck, MD
• Phone: +32 3 650 50 56
• Email: vincent.de.coninck[@]klina.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 870
• Est. completion date: December 18, 2024
• Est. primary completion date: December 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Radiation Exposure
• Urolithiasis

Intervention

Radiation:
• frames per second
Other settings for frames per second

Locations

Country	Name	City	State
Belgium	AZ Klina	Brasschaat	Antwerp
Belgium	UZA	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limit	Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL	1 year
Secondary	Difference in PRD	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	1 year
Secondary	PRD different centres	PRD differ between the different participating urologists and centres	1 year
Secondary	PRD difference complicated cases	PRD difference between normal and complicated cases	1 year