Study of the Patient Radiation Dose During Five Endourological Procedures

NCT ID: NCT06384105

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 870 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2024-12-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FPS 3-5

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

Group Type: EXPERIMENTAL

frames per second

Intervention Type: RADIATION

Other settings for frames per second

FPS >5-8

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

Group Type: EXPERIMENTAL

frames per second

Intervention Type: RADIATION

Other settings for frames per second

Interventions

frames per second

Other settings for frames per second

Intervention Type: RADIATION

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Vincent De Coninck

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincent De Coninck, MD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

AZ Klina

Brasschaat, Antwerp, Belgium

Site Status: RECRUITING

UZA

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Vincent De Coninck, MD

Role: CONTACT

vincent.de.coninck@klina.be

+32 3 650 50 56 ext. +32

Stefan De Wachter, MD

Role: CONTACT

stefan.de.wachter@uza.be

+32 3 821 33 68 ext. +32

Facility Contacts

Vincent De Coninck, MD

Role: primary

vincent.de.coninck@klina.be

+32 3 650 50 56 ext. +32

Stefan De Wachter, MD

Role: primary

stefan.de.wachter@uza.be

+32 3 821 33 68 ext. +32

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

PRDE1

Identifier Type: -

Identifier Source: org_study_id