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Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

Rakstu tulkošanu var veikt tikai reģistrēti lietotāji
Ielogoties Reģistrēties
Saite tiek saglabāta starpliktuvē
StatussPieņemšana darbā
Sponsori
Chinese University of Hong Kong

Atslēgvārdi

Abstrakts

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.

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

Bladder Cancer
Hyperthermia
Chemotherapy Effect

Iejaukšanās / ārstēšana

Other: Hyperthermic intravesical chemotherapy

Fāze

Fāze 1

Roku grupas

RokaIejaukšanās / 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 studijāmAll
Pieņem veselīgus brīvprātīgos
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]

Complications which occur within 30 days after the experimental treatment

Sekundārie iznākuma mērījumi

1. Hyperthermic intravesical chemotherapy instillation rate [One day after surgery]

Rate of hyperthermic intravesical chemotherapy instillation given after the operation

2. Duration of urethral catheterisation [Two days after the experimental treatment]

Duration of urethral catheterisation after the experimental treatment

3. Rate of bladder irrigation [One day after the experimental treatment]

Rate of bladder irrigation given after the experimental treatment

4. Duration of bladder irrigation [Two days after the experimental treatment]

Duration of bladder irrigation after the experimental treatment

5. Hospital stay [Three days after the experimental treatment]

Duration of hospital stay for the experimental treatment

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