Examining patient radiation dose during common 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
This study is testing how to reduce radiation exposure for patients during common kidney and urinary procedures while still getting good results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 870 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiteit Antwerpen Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Brasschaat, Antwerp and 1 other locations) |
| Trial ID | NCT06384105 on ClinicalTrials.gov |
What this trial studies
This study investigates the patient radiation dose (PRD) associated with five frequently performed endourological procedures that utilize fluoroscopy. By adjusting the frames per second (FPS) settings during these procedures, the study aims to determine the optimal PRD to minimize radiation exposure while maintaining procedural efficacy. The research is conducted across multiple centers to ensure a diverse patient population and robust data collection. The procedures under examination include ureteral stent insertion/replacement, (mini-)percutaneous nephrolithotomy, ureterorenoscopy, and extracorporeal shock wave lithotripsy.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing ureteral stent insertion/replacement, ureterorenoscopy, (mini-)PCNL, or ESWL under fluoroscopic guidance.
Not a fit: Patients with bilateral cases, those undergoing diagnostic ureterorenoscopies, or procedures for upper tract urothelial carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer endourological procedures with reduced radiation exposure for patients.
How similar studies have performed: While there have been studies on radiation exposure in medical procedures, this specific approach of adjusting FPS in endourology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Brasschaat, Antwerp and 1 other locations
- AZ Klina — Brasschaat, Antwerp, Belgium (Recruiting)
- Uza — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Vincent De Coninck, MD — Universiteit Antwerpen
- Study coordinator: Vincent De Coninck, MD
- Email: vincent.de.coninck@klina.be
- Phone: +32 3 650 50 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.