Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

Not Applicable

Completed

• Conditions: Chemotherapy Effect; Bladder Cancer; Hyperthermia
• Interventions: Other: Hyperthermic intravesical chemotherapy

• Registration Number: NCT03689478
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2018-10-22
• Primary Completion: 2021-08-31
• Status Verified: 2021-12
• Study Completion: 2021-12-07
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperthermic intravesical chemotherapy	Hyperthermic intravesical chemotherapy	Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

Primary Outcome Measures

Name	Time	Method
30-day complications	Thirty days after the experimental treatment	Complications which occur within 30 days after the experimental treatment

Secondary Outcome Measures

Name	Time	Method
Duration of bladder irrigation	Two days after the experimental treatment	Duration of bladder irrigation after the experimental treatment
Hospital stay	Three days after the experimental treatment	Duration of hospital stay for the experimental treatment
Hyperthermic intravesical chemotherapy instillation rate	One day after surgery	Rate of hyperthermic intravesical chemotherapy instillation given after the operation
Duration of urethral catheterisation	Two days after the experimental treatment	Duration of urethral catheterisation after the experimental treatment
Rate of bladder irrigation	One day after the experimental treatment	Rate of bladder irrigation given after the experimental treatment

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong