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临床试验/NCT04934540
NCT04934540招募中不适用

The Global En Bloc Resection of Bladder Tumour Registry

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
2
主要终点
The complete tumour resection rate

研究概览

简要总结

The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.

详细描述

Bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. It has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. This disease represents a significant burden to the healthcare system.

Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) according to its depth of invasion. Conceptually, NMIBC is amenable to complete resection by transurethral resection of bladder tumour (TURBT) alone, while MIBC requires more aggressive treatment in the form of radical cystectomy. The gold standard in local staging is by histology, and this can be achieved by TURBT. However, conventional TURBT creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. 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 following the first TURBT; it has also been shown to improve recurrence-free survival in patients with T1 non-muscle-invasive bladder cancer. In addition, tumour fragmentation and reimplantation may lead to early disease recurrence. All these highlighted the limitations of the conventional TURBT procedure.

Transurethral en bloc resection of bladder tumour (ERBT) represents a novel surgical technique in which the bladder tumour is resected in one piece. Theoretically, ERBT may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. Although ERBT has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional TURBT. Also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look TURBT and the optimal follow-up protocol remain uncertain for this technique. Therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of ERBT in the management of bladder cancer.

Investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of ERBT and to establish its role in management of bladder cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adult patients >=18 years old with informed consent
  • Presence of bladder tumour undergoing transurethral ERBT

排除标准

  • Presence or previous history of upper tract urothelial carcinoma
  • Presence of other active malignancy
  • Pregnancy

结局指标

主要结局

The complete tumour resection rate

时间窗: One weeks after the surgery

Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins.

Recurrence-free survival for NMIBC

时间窗: Every 3 months for the first two years, and then every 6 months for the next three years.

Recurrence-free survival for patients with non-muscle-invasive bladder cancer

次要结局

  • Proper staging rate for NMIBC(Seven weeks after the operation)
  • Proper staging rate for MIBC(Seven weeks after the operation)
  • Complete tumour resection rate for MIBC(Seven weeks after the operation)
  • Successful ERBT rate(Immediately post-operative)
  • Negative circumferential resection margin rate(One week after the operation)
  • Negative deep resection margin rate(One week after the operation)
  • Detrusor muscle sampling rate(One week after the operation)
  • Occurrence of obturator reflex(Intra-operative)
  • Operative time(Immediately post-operative)
  • Rate of mitomycin C instillation(Immediately post-operative)
  • Duration of bladder irrigation(Three days after the operation)
  • Hospital stay(Three days after the operation)
  • 30-day complications(Thirty days after the operation)
  • Progression-free survival(Every 3 months for the first two years, and then every 6 months for the next three years.)

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 (2)

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