Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

Study Overview
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Brief Summary
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This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.

Detailed Description
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The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.

Official Title
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A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)

Conditions
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Bladder Cancer, Hyperthermia, Chemotherapy Effect

Intervention / Treatment
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* Other: Hyperthermic intravesical chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or above with informed consent Exclusion Criteria: ECOG performance status ≥2 ASA 4 or above History of bleeding disorder Any use of anti-coagulants Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperthermic intravesical chemotherapy<br>Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour | Other: Hyperthermic intravesical chemotherapy<br>* Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day complications | Complications which occur within 30 days after the experimental treatment | Thirty days after the experimental treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperthermic intravesical chemotherapy instillation rate | Rate of hyperthermic intravesical chemotherapy instillation given after the operation | One day after surgery | 
| Duration of urethral catheterisation | Duration of urethral catheterisation after the experimental treatment | Two days after the experimental treatment | 
| Rate of bladder irrigation | Rate of bladder irrigation given after the experimental treatment | One day after the experimental treatment | 
| Duration of bladder irrigation | Duration of bladder irrigation after the experimental treatment | Two days after the experimental treatment | 
| Hospital stay | Duration of hospital stay for the experimental treatment | Three days after the experimental treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperthermic intravesical chemotherapy, Bladder cancer