Study of the Patient Radiation Dose During Five Endourological Procedures

NCT06384105 | Recruiting

• 1 other identifier: PRDE1
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 2

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.

Conditions

Radiation Exposure; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Dose limit

  Dose limit for the PRD during the insertion or replacement of a ureteral stent, URS, PCNL and ESWL

  1 year

Secondary Outcomes (3)

• Difference in PRD

  1 year

• PRD different centres

  1 year

• PRD difference complicated cases

  1 year

Study Arms (2)

FPS 3-5

EXPERIMENTAL

Frames per second are set at 3-5 at the beginning of the procedure

Radiation: frames per second

FPS >5-8

EXPERIMENTAL

Frames per second are set at \>5-8 at the beginning of the procedure

Radiation: frames per second

Interventions

frames per second RADIATION

Other settings for frames per second

FPS 3-5; FPS >5-8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (2)

AZ Klina

Brasschaat, Antwerp, 2930, Belgium

RECRUITING

UZA

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vincent De Coninck, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent De Coninck, MD

CONTACT

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

Stefan De Wachter, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 25, 2024
• Study Start: December 19, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)