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

The International Alliance of Urolithiasis

Status: Unknown

Conditions: Kidney Stone

Treatments: Procedure: Super-mini percutaneous nephrolithotomy (SMP); Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04317443

2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: Accepts Healthy Volunteers

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）

Trial design

250 participants in 2 patient groups

Super-Mini Percutaneous Nephrolithotomy

Description:

Patients undergo SMP

Treatment:

Procedure: Super-mini percutaneous nephrolithotomy (SMP)

Extracorporeal Shock Wave Lithotripsy

Description:

Patients undergo ESWL

Treatment:

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)