Clinical trial NCT03689478: Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT
Official title: A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Hyperthermia
Chemotherapy Effect
Keywords: Hyperthermic intravesical chemotherapy
Bladder cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-arm study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day complications
timeFrame: Thirty days after the experimental treatment
Secondary outcomes:
measure: Hyperthermic intravesical chemotherapy instillation rate
timeFrame: One day after surgery
measure: Duration of urethral catheterisation
timeFrame: Two days after the experimental treatment
measure: Rate of bladder irrigation
timeFrame: One day after the experimental treatment
measure: Duration of bladder irrigation
timeFrame: Two days after the experimental treatment
measure: Hospital stay
timeFrame: Three days after the experimental treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
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citation: Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
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