F-URS and Mini PCNL for Pediatric Urolithiasis

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Procedure: Mini PCNL (mini percutaneous nephrolithotomy); Procedure: RIRS (retrograde intrarenal surgery/ flexible URS)

Detailed Description

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recurrence and multiple interventions on the kidney Over the last decades, the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided.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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramy F Elbaz; Phone Number: 01092759184; Email: ramifrag7@gmail.com
• Study Contact Backup: Name: Ahmed Shoma; Phone Number: 01223766818

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Urology and nephrology center
      • Contact: Ramy Elbaz, MD; Phone Number: 00201092759184; Email: ramifrag7@gmail.com
      • Contact: Ahmed Shoma, PhD; Phone Number: +201223766818

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mini PCNL (mini percutaneous nephrolithotomy); Under general anesthesia, a 5/ 6 Fr ureteric catheter will be placed in the pelvicalyceal system. then the patient is turned to the prone position. A puncture will be done using an 18 G needle under fluoroscopy guidance. The tract will be dilated up to 15 F and then a sheath will be placed. A 12 F nephoscope (MIP-M, Karl Storz Endoscopy, Tuttlingen, Germany) will be used. Stone fragmentation will be performed using holmium YAG Laser energy. Then, Fragments will be evacuated using vacuum cleaner effect, tipless basket, or 5 FR stone forceps for stone analysis. A nephrostomy tube 12 Fr will be fixed at the end of the procedure.	Procedure: Mini PCNL (mini percutaneous nephrolithotomy); half of the cases will be treated using mini PCNL
Active Comparator: RIRS (retrograde intrarenal surgery/ flexible URS); Under general anesthesia, the children will be placed in the lithotomy position . Cystoscopy or rigid ureteroscopy will be performed to place a hydrophilic guidewire to the renal pelvis under fluoroscopic guidance. After passing a 0.035/0.038-inch safety guidewire into the renal pelvis, a ureteral access sheath will be placed (9.5/11.5 Fr, 35 cm) will be used according to the surgeon preference. . RIRS will be performed using a single use digital Flexible ureteroscopy . A manual irrigation pump system will be used to hydro dilate the ureter during ureteroscopy. The stones will be fragmented with a holmium:YAG laser until they will be deemed small enough to pass spontaneously. Some residual fragments will be removed by tipless nitinol basket for stone analysis. A double-J stent OR URETERIC CATHETER will be placed at the end of the procedure based on surgeon's decision. .	Procedure: RIRS (retrograde intrarenal surgery/ flexible URS); THE OTHER HALF WILL BE TRAETED USING Flexible URS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the primary outcome, the stone-free rate	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.	at 4 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Secondary outcomes, perioperative parameters	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	intraoperative and first day postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the tertiary outcome. post operative pain score	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)	at first day post operative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ramy F Elbaz, Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): April 5, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 22.08.684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: plan to share the surgical techniques in both arms, post operative outcomes and statistics results
• IPD Sharing Time Frame: after 4 months for 6 months
• IPD Sharing Access Criteria: via email: ramifrag7@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No