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

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

Sponsors

Lead sponsor: The International Alliance of Urolithiasis

Source 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.

Overall Status Not yet recruiting
Start Date May 1, 2020
Completion Date September 1, 2021
Primary Completion Date May 1, 2021
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Stone free rate 3-months
Secondary Outcome
Measure Time Frame
blood loss Postoperative day 1
auxiliary procedures Postoperative month 3
hospital stay Postoperative month 3
complications Postoperative month 3
Enrollment 250
Condition
Intervention

Intervention type: Procedure

Intervention name: Super-mini percutaneous nephrolithotomy (SMP)

Description: 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.

Arm group label: Super-Mini Percutaneous Nephrolithotomy

Intervention type: Procedure

Intervention name: Extracorporeal Shock Wave Lithotripsy (ESWL)

Description: 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.

Arm group label: Extracorporeal Shock Wave Lithotripsy

Eligibility

Sampling method: Probability Sample

Criteria:

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)

Gender: All

Minimum age: N/A

Maximum age: 14 Years

Healthy volunteers: Accepts Healthy Volunteers

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Super-Mini Percutaneous Nephrolithotomy

Description: Patients undergo SMP

Arm group label: Extracorporeal Shock Wave Lithotripsy

Description: Patients undergo ESWL

Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov