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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 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

72

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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
Outros nomes:
  • Mini-Percutaneous Nephrolithotomy
Comparador Ativo: 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
Outros nomes:
  • Mini-Percutaneous Nephrolithotomy

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Management of pediatric renal stones
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Youssef Mahmoud kotb, Professor, Urology Department, Faculty of Medicine, Ain Shams University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

10 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

9 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2026

Primeira postagem (Real)

13 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Management of Renal Stones

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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