Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT
Atslēgvārdi
Abstrakts
Apraksts
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.
Datumi
Pēdējoreiz pārbaudīts: | 12/31/2019 |
Pirmais iesniegtais: | 09/26/2018 |
Paredzētā reģistrācija iesniegta: | 09/26/2018 |
Pirmais izlikts: | 09/27/2018 |
Pēdējais atjauninājums iesniegts: | 01/20/2020 |
Pēdējā atjaunināšana ievietota: | 01/22/2020 |
Faktiskais studiju sākuma datums: | 10/21/2018 |
Paredzamais primārās pabeigšanas datums: | 04/29/2020 |
Paredzamais pētījuma pabeigšanas datums: | 05/30/2020 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Other: Hyperthermic intravesical chemotherapy
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
Experimental: Hyperthermic intravesical chemotherapy Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour | Other: Hyperthermic intravesical chemotherapy Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
Dzimumi, kas ir piemēroti studijām | All |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | 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 |
Rezultāts
Primārie rezultāti
1. 30-day complications [Thirty days after the experimental treatment]
Sekundārie iznākuma mērījumi
1. Hyperthermic intravesical chemotherapy instillation rate [One day after surgery]
2. Duration of urethral catheterisation [Two days after the experimental treatment]
3. Rate of bladder irrigation [One day after the experimental treatment]
4. Duration of bladder irrigation [Two days after the experimental treatment]
5. Hospital stay [Three days after the experimental treatment]