A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 30-day complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or above with informed consent
排除标准
- •ECOG performance status ≥2
- •ASA 4 or above
- •History of bleeding disorder
- •Any use of anti-coagulants
- •Pregnancy
结局指标
主要结局
30-day complications
时间窗: Thirty days after the experimental treatment
Complications which occur within 30 days after the experimental treatment
次要结局
- Duration of bladder irrigation(Two days after the experimental treatment)
- Hospital stay(Three days after the experimental treatment)
- Hyperthermic intravesical chemotherapy instillation rate(One day after surgery)
- Duration of urethral catheterisation(Two days after the experimental treatment)
- Rate of bladder irrigation(One day after the experimental treatment)
研究者
Jeremy Yuen Chun TEOH
Assistant Professor
Chinese University of Hong Kong
