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Feasibility of HISA During TURBT for NMIBC

8 de septiembre de 2026 actualizado 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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Recruitment
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Cancer-related Quality of Life and General Treatment Effects
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CAMC Health System

Colaboradores

West Virginia Clinical and Translational Science Institute

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

29 de febrero de 2028

Finalización del estudio (Estimado)

31 de mayo de 2030

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Publicado por primera vez (Actual)

14 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 25-1357
  • U54GM104942 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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