A Prospective Observational Comparison of SMP and ESWL for the Treatment of Renal Stones ≥20 mm in Children (IAU-04)

• Conditions: Kidney Stone
• Interventions: Procedure: Super-mini percutaneous nephrolithotomy (SMP); Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

• Registration Number: NCT04317443
• Lead Sponsor: The International Alliance of Urolithiasis

Brief Summary

ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.

Detailed Description

To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30
• Study Start: 2020-05-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Children ≤14 years old with renal Stones ≥20 mm
• Willing and able to sign informed consent
• Normal renal function
• No stone-related surgical history
• American Society of Anesthesiology (ASA) score 1-2

Exclusion Criteria

• Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
• Uncorrected UTI
• Abnormal coagulation function
• Morbid obese children (BMI≥35）

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Super-Mini Percutaneous Nephrolithotomy	Super-mini percutaneous nephrolithotomy (SMP)	Patients undergo SMP
Extracorporeal Shock Wave Lithotripsy	Extracorporeal Shock Wave Lithotripsy (ESWL)	Patients undergo ESWL

Primary Outcome Measures

Name	Time	Method
Stone free rate	3-months	Stone clearance on the computed tomography (2mm thickness)

Secondary Outcome Measures

Name	Time	Method
blood loss	Postoperative day 1	Number of participants requiring blood transfusion after the procedure
complications	Postoperative month 3	Rate of postoperative complications using the Clavien-Dindo system
hospital stay	Postoperative month 3	From date of admission until the date of discharge,length of hospital stay
auxiliary procedures	Postoperative month 3	Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy