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NCT Number: NCT03689478

Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermic intravesical chemotherapy

Other

Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour

Primary outcomes

  1. 30-day complications

    Time frame: Thirty days after the experimental treatment

    Complications which occur within 30 days after the experimental treatment

Secondary outcomes

  1. Hyperthermic intravesical chemotherapy instillation rate

    Time frame: One day after surgery

    Rate of hyperthermic intravesical chemotherapy instillation given after the operation

  2. Duration of urethral catheterisation

    Time frame: Two days after the experimental treatment

    Duration of urethral catheterisation after the experimental treatment

  3. Rate of bladder irrigation

    Time frame: One day after the experimental treatment

    Rate of bladder irrigation given after the experimental treatment

  4. Duration of bladder irrigation

    Time frame: Two days after the experimental treatment

    Duration of bladder irrigation after the experimental treatment

  5. Hospital stay

    Time frame: Three days after the experimental treatment

    Duration of hospital stay for the experimental treatment

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: I-HIVEC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2018
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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