Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Feasibility of HISA During TURBT for NMIBC

8 de setembro de 2026 atualizado por: Michael Stencel, CAMC Health System

A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer

The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer.

The main questions it aims to answer are:

Can heated saline be given during bladder tumor removal surgery safely?

Does using heated saline keep the bladder tumor from coming back?

Researchers will compare the heated saline to room temperature saline to see if the heated saline works to prevent the bladder tumor from coming back.

Participants will:

  • Have heated saline or room temperature saline during bladder tumor surgery
  • Visit the clinic at 2 weeks, 3 and 6 months after bladder tumor surgery
  • Complete questionnaires about quality of their life and symptoms before and after surgery
  • Provide urine samples to test your urine at each visit before and after surgery
  • To have a cystoscopy to check your bladder for tumors

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Non-muscle invasive bladder cancer (NMIBC) represents 75% of bladder cancer cases and recurs in up to 79% of patients. West Virginia carries disproportionately high bladder cancer incidence due to smoking, aging population, and occupational exposures. High recurrence requires frequent cystoscopy and intravesical therapy, creating a burden for rural Appalachian patients. New strategies to reduce recurrence and treatment are urgently needed.

Hyperthermic intravesical chemotherapy improves drug penetration and tumor cell sensitivity. However, the benefit of applying hyperthermic saline intraoperatively during resection of the bladder tumor is unknown. In this randomized, two-arm study, we will randomize 40 patients with low-risk appearing NMIBC to normothermic and hyperthermic saline irrigation during bladder tumor resection. Hyperthermic irrigation will be delivered at 42 ± 2° Celsius using the Stryker Thermaclear FluidSmart system. All patients will receive standard postoperative gemcitabine instillation. Follow-up visits will occur at 2 weeks, 3 and 6 months. The primary goal is feasibility, defined as 80% protocol adherence to hyperthermic irrigation. Secondary goals include safety, logistics, and patient retention. Additional outcomes include recurrence, adverse events, and patient-reported quality-of-life scores.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

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

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Male or female patients
  • Age from 18 to 89 years old
  • Visual diagnosis of a papillary tumor(s) ≤ 3 cm
  • Transurethral resection of bladder tumor (TURBT)
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2
  • Glomerular filtration rate (GFR) ≥ 30 mL/min

Exclusion Criteria:

  • Ages less than 18 years of age
  • Pregnant women
  • Prisoners
  • Patients with evidence of distant metastasis
  • Patients with histologically confirmed high-risk NMIBC prior to and after TURBT
  • Patients with prior carcinoma is situ diagnosis
  • Patients with an active infection defined as documented urinary tract infection based on preoperative urine analysis or urine culture
  • Immunosuppression defined as a patient with leukopenia or taking any active immunosuppressive medication
  • Patients that had an intraoperative perforation during TURBT
  • Patients participating in another clinical trial with this urologic cancer diagnosis
  • Postoperative bladder instillation failure defined as the inability to deliver and maintain the planned volume of instilled fluid within the bladder for at least 30 minutes

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
Experimental: HISA
The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT.
Dispositivo: HISA
The intervention arm (HISA) will be treated in the same way as the control arm with the addition of administering hyperthermic (42.0 ± 2°C) intravesical saline during the TURBT. Bladder irrigation with 1g of gemcitabine will be delivered in the immediate postoperative setting. The Thermaclear FluidSmart Fluid management system (Stryker, MI) will be used to administer and irrigate the bladder with normothermic or hyperthermic intravesical saline during the TURBT.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient Recruitment
Prazo: one year
The primary outcome will be patient recruitment. Patient recruitment will be the number of patients recruited divided by the total number of eligible patients.
one year
Protocol Adherence for HISA Treatment
Prazo: one year
Protocol adherence will be assessed per case. Full adherence is defined as: (1) assigned saline used; (2) temperature maintained at 42.0 ± 2.0°C for ≥80% of intended exposure; (3) delivery of hyperthermic saline occurred during the specified operative window, and (4) postoperative instillation of 1g gemcitabine for 60 minutes.
one year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
Prazo: Three years
To assess postoperative complications, adverse events, and readmission rates at 30- and 90-days. Adverse events will be monitored during the study for up to 90 days for each patient, assessed and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Three years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Overall Cancer-related Quality of Life and General Treatment Effects
Prazo: From TURBT to 6 months after TURBT
Quality of life will be assessed at the preoperative visit and follow-up visits at 2-weeks, 3 months, and 6 months using the EORTC QLQ Core Questionnaire (EORTC QLQ-C30, version 3.0).
From TURBT to 6 months after TURBT
Recurrence of NMIBC
Prazo: From time of TURBT to 6 months after TURBT
The proportion of patients with recurrence of NMIBC will be determined. Recurrence will be defined as the percentage of patients with the reappearance of NMIBC tumor(s) within the bladder following transurethral resection of bladder tumor (TURBT). The event will be defined as the earliest date of recurrence as determined using the date of cystoscopy, biopsy, or cytology, whichever occurs first.
From time of TURBT to 6 months after TURBT
Survival of NMIBC Patients
Prazo: From time of TURBT to 6 months after TURBT
Survival will be defined as the percentage of patients who have survived after TURBT without any recurrence or death from any cause. The event will be defined as the length of time until cancer recurrence or death from any cause using the date of cystoscopy, biopsy, or death certificate date whichever occurs first.
From time of TURBT to 6 months after TURBT
Patient Quality of Life Concerns and Symptoms of HISA Treatment of NMIBC
Prazo: From TURBT to 6 months after TURBT
Quality of life will be assessed at the preoperative visit and follow-up visits at 2weeks, 3 months, and 6 months using the EORTC QLQ-NMIBC 24.
From TURBT to 6 months after TURBT

Colaboradores e Investigadores

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

Patrocinador

CAMC Health System

Colaboradores

West Virginia Clinical and Translational Science Institute

Investigadores

  • Investigador principal: Michael G Stencel, DO, CAMC Health System

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 (Estimado)

15 de agosto de 2026

Conclusão Primária (Estimado)

29 de fevereiro de 2028

Conclusão do estudo (Estimado)

31 de maio de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

9 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2026

Primeira postagem (Real)

14 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 25-1357
  • U54GM104942 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared to protect patient privacy and confidentiality. The study includes sensitive health information, and even when data are de-identified, there is a small risk that participants could be identified. In addition, there are no current plans or resources to support data sharing agreements or external data requests. Summary results will be reported in publications instead.

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

Sim

produto fabricado e exportado dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever