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

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04317443
• Other study ID #: 2020-01
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: April 2020
• Source: The International Alliance of Urolithiasis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

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 (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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The International Alliance of Urolithiasis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	Stone clearance on the computed tomography (2mm thickness)	3-months
Secondary	blood loss	Number of participants requiring blood transfusion after the procedure	Postoperative day 1
Secondary	auxiliary procedures	Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy	Postoperative month 3
Secondary	hospital stay	From date of admission until the date of discharge,length of hospital stay	Postoperative month 3
Secondary	complications	Rate of postoperative complications using the Clavien-Dindo system	Postoperative month 3