Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06571617

F-URS and Mini PCNL for Pediatric Urolithiasis

To compare RIRS versus mini-perc PNL in the management of medium size pediatric renal stones (10-20 mm) through a RCT.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Pediatric urolithiasis has become a major health problem, especially in the developing countries. It is a well-known risk factor for renal impairment and end-stage kidney disease (ESKD). Also, it's associated with a bad quality of life (Qol) for both parents and child. Children represent 2-3% of the total population of stone-formers. Similar to adult urolithiasis, the prevalence of pediatric stones is widely variable in different parts of the world. it changes with sex, race, geographical and climatic factors.

Renal stones in pediatric patients are usually caused by an underlying disorder, such as anatomical and metabolic anomalies or recurrent urinary tract infections, So, children with renal stones are at higher risk for recurrence and multiple interventions on the kidney Over the last decades, the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided. According to the last guidelines from the European Association of Urology (EAU) and the American urological association (AUA), the standard treatment of renal stones between1-2 cm is shockwave lithotripsy (SWL), percutaneous nephrolithotomy (PNL) and retrograde intrarenal surgery (RIRS). However, the first choice between these modalities is still controversial until now.

SWL is one of the most effective treatment options for pediatric stones, however, its long-term effect on developing kidneys is not clear yet. Also, its efficacy decreases significantly with increasing stone size and multiplicity. The requirement for multiple sessions and the need for general anesthesia in children are other drawbacks of this procedure.

PNL has significantly higher stone-free rates (SFR) and lower requirements for auxiliary procedures compared with SWL. This trend is further promoted by the introduction of miniaturized PNL (mini-perc), which is postulated to be less invasive compared with standard PNL because of the miniaturized instruments. However, PNL may present problems in children, despite modifications, such as the "mini-perc," because of the small size and mobility of the pediatric kidney, friable renal parenchyma, and the small size of the collecting system.

On the other hand, the quality of flexible ureteroscopy and endoscopic instruments showed an outstanding development over the last years which made RIRS a feasible option for pediatric renal stones. Experience suggests that flexible ureteroscopy has a lower risk of kidney damage and bleeding. However, the disadvantage of RIRS in children includes the need toindwell double-J stent in advance, the risk of ureteral injury, and the high cost of equipment purchase and maintenance, which may limit the application of RIRS in children with upper urinary tract calculi.

Until now, there is a few number of randomized trials compared mini-perc PNL versus RIRS for pediatric renal stones. SO, there is no clear evidence for the superiority of one option over the other regarding stone- free rate, complication rate, auxiliary procedures, and second sessions.

Recently, a new Trifecta tool which includes stone-free status in a single session without complications was set in motion to help standard reporting of the outcome of stone intervention in line with assessing its efficacy and safety.

In the present study, we will try to overcome the limitations of the previous studies by designing a prospective randomized controlled trial (RCT). To the best of our knowledge, the present study is the first RCT comparing mini-perc PNL versus RIRS for the management medium -size renal stones (10-20mm) in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 12 years or younger
  • American society of anesthesia (ASA) score I or II.
  • Renal stone measured between 10-20 mm.
  • An informed consent obtained from their parents

Exclusion criteria

  • Bleeding tendency
  • Active urinary tract infection (UTI).
  • Renal anatomical abnormalities (ectopic kidney, horseshoe kidney, ADPCK).
  • Skeletal deformities
  • Concomitant ureteric stone or stricture.

Treatment and study plan

Mini PCNL (mini percutaneous nephrolithotomy)

Procedure

half of the cases will be treated using mini PCNL

RIRS (retrograde intrarenal surgery/ flexible URS)

Procedure

THE OTHER HALF WILL BE TRAETED USING Flexible URS

Primary outcomes

  1. the primary outcome, the stone-free rate

    Time frame: at 4 weeks postoperatively

    no evidence of any residual fragment by NCCT or KUB or clinical insignificant residual fragments (CIRF) ≤ 4 mm in maximum diameter in a single session within the first month postoperatively.

Secondary outcomes

  1. The Secondary outcomes, perioperative parameters

    Time frame: intraoperative and first day postoperatively

    intraoperative complications, operation time in minutes, fluoroscopy time in seconds, lasing time in seconds, laser energy in joles, hemoglobin deficit, postoperative complications, hospital stay in days

Other outcomes

  1. the tertiary outcome. post operative pain score

    Time frame: at first day post operative

    assessment of pain at postoperative day 1 (PODI), For children < 7.5 years, we will use the validated Arabic version of Wong-Baker FACES scale (WBF). For older children, we will use the validated Arabic version of visual analogue scale (VAS)

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Shoma

CONTACT

01223766818

Ramy F Elbaz

CONTACT

[email protected]

01092759184

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Retrograde Intrarenal Surgery Versus Mini-Percutaneous Nephrolithotomy for Treatment of Medium Size Pediatric Renal Stones (10-20millimeters). A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.