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Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath

10 augustus 2026 bijgewerkt door: Mohamed Ramadan, Ain Shams University

A Comparative Study on the Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath for the Management of Renal Stones 1- 2.5 cm in Pediatric Age Group

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles.

Suction has emerged as a potentially transformative adjunct in both percutaneous nephrolithotomy (PCNL) and RIRS. Recent studies evaluating various suction mechanisms during RIRS and mini-PCNL have demonstrated multiple benefits, including reduced operative time, higher stone-free rates (SFR), decreased intrarenal pressure (IRP) and temperature, as well as enhanced intraoperative visualization.

Both FANS-UAS in RIRS and VAAS in Mini-PCNL have shown promising outcomes in the pediatric population. Taken together, these findings suggest that suction-assisted technologies whether in RIRS or Mini-PCNL enhance both efficacy and safety in pediatric stone management.

Studie Overzicht

Toestand

Werving

Interventie / Behandeling

Gedetailleerde beschrijving

In children, renal stones commonly result from congenital anatomical defects, metabolic abnormalities, or recurrent urinary tract infections. Consequently, urolithiasis is more frequent in this age group and often requires more than one surgical intervention for complete management.

Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and complication profiles .

Currently, the majority of pediatric renal stones can be managed effectively using shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), or percutaneous nephrolithotomy (PCNL). Surgical interventions such as open, laparoscopic, or robotic surgery are reserved for a minority of cases involving anatomical abnormalities. As spontaneous passage of residual fragments occurs in only 20-25% of cases, achieving complete stone clearance is essential to minimize the risk of recurrence and additional interventions.

Technological advancements in endourological instrumentation have primarily aimed at minimizing procedure-related morbidity, including blood loss, postoperative pain, and renal injury. Consequently, miniaturized endoscopes and reduced-caliber access tracts (11-20 Fr) were developed, leading to the emergence of Mini-PCNL techniques specifically adapted for the management of large renal stones in pediatric patients.

The use of retrograde surgical approaches has expanded the capability to treat larger renal stones, despite often resulting in extended operative times. Due to its favorable safety profile and reduced complication rates, RIRS has gained acceptance as a preferred option for managing larger stones in pediatric patients.

For stones larger than 20 mm, RIRS monotherapy is associated with lower stone-free rate (SFR) compared to Mini-PCNL. However, RIRS offers advantages including reduced radiation exposure, fewer complications, and shorter hospital stay.

The Mini-PCNL and RIRS provide comparable efficacy and complication rates in the treatment of pediatric renal stones up to 2.5 cm. Furthermore, the study found that RIRS was associated with significantly shorter hospital stays, reduced radiation exposure, and decreased fluoroscopy time compared to Mini-PCNL.

Suction has been utilized in endourology for over 25 years, primarily in conjunction with ultrasound and ballistic lithotripsy devices, and more recently through the use of suction sheaths during PCNL. Intraoperative suction has been introduced as an effective method to remove residual fragments (RFs), thereby reducing the need for manual extraction with baskets.

Suction has also been employed in RIRS, providing multiple advantages including improved stone fragmentation and dusting, enhanced removal of debris and fragments, reduction of intra-renal temperature and pressure, as well as better intraoperative visualization.

In a prospective multicenter trial, Gauhar et al. demonstrated that the flexible and navigable suction ureteral access sheath (FANS-UAS) is safe and effective for use in pediatric RIRS, yielding high stone-free rates with low complication rates. This supports its emerging role as a valuable innovation in pediatric endourological procedures.

The initial experience using a semi-closed-circuit vacuum-assisted mini-percutaneous nephrolithotomy (Mini-PCNL) system in pediatric patients, achieving an 80% stone-free rate with no intraoperative complications and only minor postoperative events. This technique, which integrates continuous irrigation inflow with suction-controlled outflow, was found to be a safe and effective option for managing complex renal stones in children while maintaining acceptable operative times.

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

- Renal stone burden 1- 2.5 cm confirmed by imaging (CT or ultrasound).

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Untreated Urinary tract infection (UTI) proved by urine culture and sensitivity.
  • Uncorrected coagulopathy.
  • Anatomical anomalies or ureteral stricture precluding either surgical approach.
  • Previous surgical intervention on the same kidney.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Group A(Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath )
About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Flexible Ureteroscopy with Flexible Navigable Suction Ureteral Access Sheath
To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm
Andere namen:
  • Mini-Percutaneous Nephrolithotomy
Actieve vergelijker: Group B(Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath )
About 36 pediatric patients suffering from Renal Stones 1- 2.5 cm will be treated by Mini-Percutaneous Nephrolithotomy with Vacuum-Assisted Access Sheath
To compare the efficacy and safety of flexible ureteroscopy using a flexible and navigable suction ureteral access sheath (FANS-UAS) versus mini-percutaneous nephrolithotomy (Mini-PCNL) using a vacuum-assisted access sheath (VAAS) in the management of pediatric renal stones 1-2.5 cm
Andere namen:
  • Mini-Percutaneous Nephrolithotomy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Management of pediatric renal stones
Tijdsspanne: 6 months
To compare stone-free rate (SFR) at 1 month after the procedure between RIRS using FURS-UAS and mini-PCNL using VASS in pediatric patients with renal stones 1-2.5 cm
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Youssef Mahmoud kotb, Professor, Urology Department, Faculty of Medicine, Ain Shams University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

10 juni 2027

Studieregistratiedata

Eerst ingediend

9 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 augustus 2026

Eerst geplaatst (Werkelijk)

13 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Management of Renal Stones

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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