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

A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Stone
• Intervention / Treatment: Procedure: Super-mini percutaneous nephrolithotomy (SMP); Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

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 Type: Observational
• Enrollment (Anticipated): 250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients undergoing SWL and SMP

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Super-Mini Percutaneous Nephrolithotomy; Patients undergo SMP	Procedure: Super-mini percutaneous nephrolithotomy (SMP); SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon.
Extracorporeal Shock Wave Lithotripsy; Patients undergo ESWL	Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL); ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Stone clearance on the computed tomography (2mm thickness)	3-months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The International Alliance of Urolithiasis

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (ACTUAL): March 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: children; percutaneous nephrolithotomy; pcnl; miniperc; smp
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi
• Other Study ID Numbers: 2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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