Comparison of ESWL and Mini-PCNL for High-Density Renal Stones in Children

NCT07360041 | Completed DMC

• 1 other identifier: FMASUMD127/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric nephrolithiasis is an increasing health problem, with rising prevalence particularly in certain geographic regions. Management options for pediatric renal stones include extracorporeal shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL), and retrograde intrarenal surgery. According to the EAU/ESPU guidelines, SWL is recommended as a first-line treatment for most renal stones; however, its success is significantly influenced by stone size, location, and density. High-density renal stones (≥1000 Hounsfield Units) are associated with lower stone-free rates after SWL and higher retreatment rates. Miniaturized percutaneous nephrolithotomy (mini-PNL) has emerged as an effective alternative, offering high stone-free rates with reduced morbidity compared to standard PNL due to the use of smaller access sheaths. While adult studies have demonstrated superior outcomes of mini-PNL over SWL for high-density renal stones, there is a lack of comparative data in the pediatric population. This prospective randomized controlled study aims to compare the efficacy and safety of mini-PNL versus SWL in children aged 2 to 12 years with single, non-lower pole, high-density (≥1000 HU), medium-sized (10-20 mm) renal stones. Eligible patients will be randomized into two equal groups to undergo either mini-PNL or SWL under general anesthesia. The primary outcome is the stone-free rate, defined as no residual stone or residual fragments ≤4 mm on non-contrast computed tomography performed three months after the procedure. Secondary outcomes include operative and fluoroscopy times, hemoglobin drop, length of hospital stay, retreatment and ancillary procedure rates, and postoperative complications graded according to the Clavien-Dindo classification. The study will be conducted at a single tertiary referral center. All participants' parents or legal guardians will provide informed consent in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki. This study aims to provide evidence to guide optimal management of pediatric patients with high-density renal stones.

Conditions

Renal Stones; Calculus; Pediatric; Endoscopy

Keywords

10-20 mm non lower calyceal high density renal stones; renal; calculus; pediatrics; ESWL; PCNL

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy assessed as stone free rate

  defined as no or stone fragment residual ≤ 4 mm by non-contrast computed tomography (NCCT)

  3 months

Study Arms (2)

Miniaturized Percutaneous Nephrolithotomy (mini-PNL)

ACTIVE COMPARATOR

Miniaturized Percutaneous Nephrolithotomy (mini-PNL)

Procedure: Miniaturized Percutaneous Nephrolithotomy (mini-PNL)

Shock Wave Lithotripsy (SWL)

ACTIVE COMPARATOR

Shock Wave Lithotripsy (SWL)

Procedure: Shock Wave Lithotripsy (SWL)

Interventions

Miniaturized Percutaneous Nephrolithotomy (mini-PNL) PROCEDURE

Mini-PNL: All procedures will be done in the prone position. The target calyx will be punctured using fluoroscopic guidance with an 18-GA sheathed needle, and tract dilatation will be achieved using Amplantz dilators up to 16-18 Fr according to patient age. The holmium: YAG laser will be used to perform the stone fragmentation. Standard 12-Fr rigid nephroscope will be used for stone retrieval and fragmentation. A clamped nephrostomy tube will be placed routinely to reduce the bleeding for 24 h in all cases. The nephrostomy tube and the ureteral catheter will be removed on first and second postoperative days if there will be no complications.

Miniaturized Percutaneous Nephrolithotomy (mini-PNL)

Shock Wave Lithotripsy (SWL) PROCEDURE

The lithotripsy will be performed by an electromagnetic shockwave lithotripter (Dornier Compact Sigma). The lung and genitourinary fields will be shielded for all patients. Fluoroscopy will be used to localize the stone and to monitor fragmentation.The dispensed shockwave will begin at 14 kV and escalates to its maximum power level of 20 kV. The maximum number of shocks given per session will be between 1000 and 2500 depending on patient age (1000 waves per session for children younger than 5 years and 2500 waves per session for older children, with a frequency of 70 shocks/minute). The SWL session will be stopped when no visible stone is detected, or when tiny fragments are the only visible stone remnants, or when the desired number of shocks has been given.

Shock Wave Lithotripsy (SWL)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children from ages 2 to 12
• Single renal stone pelvic, upper or middle calyceal
• Stone diameter between 1 and 2 cm in the longest axis by NCCT
• High-density (≥1000 HU) by NCCT

You may not qualify if:

• Radiolucent stones
• Co-existing renal anomalies
• Acute UTI
• Uncorrectable bleeding disorders
• Musculoskeletal deformities
• Patients with ureteral stones or ureteral obstruction

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 4240112, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis; Calculi

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: May 28, 2023
• Primary Completion: May 20, 2025
• Study Completion: September 9, 2025
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the IPD and supporting information will be available (1-feb-2026) and for how long (31-jun-2026).
• Access Criteria: Who can access the IPD? * Any qualified researcher * Researchers with an approved proposal * Only collaborators or sponsors * Researchers affiliated with an academic institution What can they access? * De-identified individual participant data * Data underlying published results Supporting documents ( study protocol, statistical analysis plan, data dictionary) How can they access it? * By submitting a research proposal * After signing a data use or confidentiality agreement * Through a secure data-sharing platform or repository * By contacting the study sponsor or principal investigator

Locations

EG (1)