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Study of the Patient Radiation Dose During Five Endourological Procedures (PRDE)

U

Universiteit Antwerpen

Status

Enrolling

Conditions

Urolithiasis
Radiation Exposure

Treatments

Radiation: frames per second

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

870 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

870 participants in 2 patient groups

FPS 3-5
Experimental group
Description:
Frames per second are set at 3-5 at the beginning of the procedure
Treatment:
Radiation: frames per second
FPS >5-8
Experimental group
Description:
Frames per second are set at \>5-8 at the beginning of the procedure
Treatment:
Radiation: frames per second

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Vincent De Coninck, MD; Stefan De Wachter, MD

Data sourced from clinicaltrials.gov

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