Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.

Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Study Overview

• Status: Completed
• Conditions: Stone, Kidney; Child, Only
• Intervention / Treatment: Procedure: ultrasonic focus Shock wave lithotripsy; Procedure: fluoroscopic focus Shock wave lithotripsy

Detailed Description

Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.

Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • Urology department - faculty of medicine, South Valley university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

Exclusion Criteria:

1. Previous percutaneous nephrolithotripsy at the same side.
2. Previous renal exploration for stones at the same side.
3. Positive urinary culture.
4. Calyceal stones

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fluoroscopic focus Shock wave lithotripsy; Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone	Procedure: ultrasonic focus Shock wave lithotripsy; successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone; Procedure: fluoroscopic focus Shock wave lithotripsy; successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone
Active Comparator: ultrasonic focus Shock wave lithotripsy; Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone	Procedure: ultrasonic focus Shock wave lithotripsy; successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone; Procedure: fluoroscopic focus Shock wave lithotripsy; successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lithotripsy or nephrolithotripsy by Shock waves	Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.	from baseline to 3 months after the Lithotripsy date.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of shockwave lithotripsy	to evaluate postoperative complications of the lithotripsy as : Incidence of Hematuria; Incidence of Fever; Incidence of UTI; Serum creatinine level in blood; Rate of hydronephrosis	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Principal Investigator: Mahmoud Moubarak, Resident, Urology department - faculty of medicine, South Valley university.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pediatric renal stones; ultrasound shock waves; fluoroscope.
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: Mahmoud Moubarak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No