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临床试验/NCT03689478
NCT03689478已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月22日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy Yuen Chun TEOH

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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