F-URS and Mini PCNL for Pediatric Urolithiasis

NCT ID: NCT06571617

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-04-05

Brief Summary

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

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and multiple interventions on the kidney Over the last decades, the management of pediatric urolithiasis had been replaced by less invasive endourological procedures and the role of open surgeries had been greatly subsided.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

Conditions

Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Mini PCNL (mini percutaneous nephrolithotomy)

Intervention Type: PROCEDURE

half of the cases will be treated using mini PCNL

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. .

Group Type: ACTIVE_COMPARATOR

RIRS (retrograde intrarenal surgery/ flexible URS)

Intervention Type: PROCEDURE

THE OTHER HALF WILL BE TRAETED USING Flexible URS

Interventions

Mini PCNL (mini percutaneous nephrolithotomy)

half of the cases will be treated using mini PCNL

Intervention Type: PROCEDURE

RIRS (retrograde intrarenal surgery/ flexible URS)

THE OTHER HALF WILL BE TRAETED USING Flexible URS

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ramy Elbaz

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramy F Elbaz

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Central Contacts

Ramy F Elbaz

Role: CONTACT

ramifrag7@gmail.com

01092759184

Ahmed Shoma

Role: CONTACT

01223766818

Facility Contacts

Ramy Elbaz, MD

Role: primary

ramifrag7@gmail.com

00201092759184

Ahmed Shoma, PhD

Role: backup

+201223766818

Other Identifiers

22.08.684

Identifier Type: -

Identifier Source: org_study_id