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Feasibility of HISA During TURBT for NMIBC

8. september 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: No HISA
The control arm (no HISA) will consist of standard intraoperative care including bladder irrigation with normothermic saline during TURBT.
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Recruitment
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of HISA Treatment-related Complicatons, Adverse Events, and Readmission Rates
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Cancer-related Quality of Life and General Treatment Effects
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CAMC Health System

Samarbeidspartnere

West Virginia Clinical and Translational Science Institute

Etterforskere

  • Hovedetterforsker: Michael G Stencel, DO, CAMC Health System

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. august 2026

Primær fullføring (Antatt)

29. februar 2028

Studiet fullført (Antatt)

31. mai 2030

Datoer for studieregistrering

Først innsendt

9. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-1357
  • U54GM104942 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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