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

NCT04317443 | Unknown DMC

• 1 other identifier: 2020-01
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Stone

Keywords

percutaneous nephrolithotomy; pcnl; miniperc; smp; children

Outcome Measures

Primary Outcomes (1)

• Stone free rate

  Stone clearance on the computed tomography (2mm thickness)

  3-months

Secondary Outcomes (4)

• blood loss

  Postoperative day 1

• auxiliary procedures

  Postoperative month 3

• hospital stay

  Postoperative month 3

• complications

  Postoperative month 3

Study Arms (2)

Super-Mini Percutaneous Nephrolithotomy

Patients undergo SMP

Procedure: Super-mini percutaneous nephrolithotomy (SMP)

Extracorporeal Shock Wave Lithotripsy

Patients undergo ESWL

Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)

Interventions

Super-mini percutaneous nephrolithotomy (SMP) PROCEDURE

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.

Super-Mini Percutaneous Nephrolithotomy

Extracorporeal Shock Wave Lithotripsy (ESWL) PROCEDURE

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.

Extracorporeal Shock Wave Lithotripsy

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients undergoing SWL and SMP

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The International Alliance of Urolithiasis: lead

MeSH Terms

Conditions

Kidney Calculi

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 23, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share