Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 13
- 主要终点
- One-year recurrence rate
研究概览
简要总结
Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.
详细描述
Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. In Hong Kong, more than 400 new cases of bladder cancer are diagnosed every year. It is a common and important disease which carries a significant burden to the health medical system.
For patients who are diagnosed to have bladder tumours upon flexible cystoscopy, transurethral resection of bladder tumour (TURBT) should be offered. Being a minimally invasive procedure, it has become the standard for the initial management of bladder cancer. This operation aims to ascertain the diagnosis, to correctly stage the tumour (T-stage) and to cure the disease in the case of non-muscle-invasive bladder cancer (NMIBC). However, in a combined analysis of 2,596 patents from 7 randomised controlled trials in patients with NMIBC, it was shown that 1-year recurrence rate ranged from 15-61%, and 5-year recurrence rate ranged from 31-78%. Despite possible complete tumour resection during TURBT, the oncological control of NMIBC is far from satisfactory.
There are two main problems with the conventional standard resection (SR) procedure. First, the bladder tumour is resected in a piecemeal manner. This results in tumour fragmentation and floating tumour cells inside the bladder. The tumour cells may re-implant on to the bladder wall and lead to early disease recurrence. Second, 'complete tumour resection' is often determined by endoscopic vision only. Due to the inherited nature of piecemeal resection, it is not possible to assess the resection margin by histological means. The charring effect to the resection bed may also hinder the judgement of a 'complete tumour resection'. Routine second-look TURBT has been advocated for selected patients (Any presence of T1 disease, G3 disease, or any absence of detrusor muscle in the first TURBT specimen) even after a 'complete tumour resection' during the first TURBT. Second-look TURBT has been shown to detect residual disease in 33-55% of the patients and upstaging of disease in 4-45% of the patients. These results highlighted the limitations of TURBT in ascertaining complete tumour resection.
Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age ≥ 18 years old with informed consent
排除标准
- •Bladder tumour base with maximal dimension of >3cm (Anticipated difficulty in retrieving the specimen en bloc)
- •Bladder tumour detected during intravesical BCG therapy (BCG failure warrants more aggressive treatment, i.e. radical cystectomy)
- •Histological diagnosis other than NMIBC
- •Presence or prior history of upper urinary tract malignancy
- •ECOG performance status ≥ 3 (Confined to bed or chair more than 50% of waking hours)
- •ASA III or above (Patient with severe systemic disease)
- •History of bleeding disorder or use of anti-coagulants
- •Pregnancy
- •Presence of other active malignancy
- •Life expectancy of less than one year
结局指标
主要结局
One-year recurrence rate
时间窗: One year after the allocated treatment
Rate of disease recurrence one year after the operation
次要结局
- Occurrence of obturator reflex(Intra-operative)
- Rate of mitomycin C instillation(One day after the allocated treatment)
- 30-day complications(Thirty days after the allocated treatment)
- Upstaging of disease upon second look transurethral resection surgery(Seven weeks after the allocated treatment)
- Detrusor muscle sampling rate(One week after the allocated treatment)
- Operative time(Immediately post-operative)
- Residual disease upon second look transurethral resection surgery(Seven weeks after the allocated treatment)
- Hospital stay(Three days after the allocated treatment)
- One-year progression rate(One year after the allocated treatment)
研究者
Jeremy Yuen Chun TEOH
Assistant Professor
Chinese University of Hong Kong