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Project

Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR study).

Funder: University Grants Committee

Funding period
HKD 590 K
USD 75 K
Funding amount
Abstract
Background  Transurethral resection of bladder tumour (TURBT) has been the standard for the initial diagnosis and treatment of non-muscle-invasive bladder cancer (NMIBC) [1]. Conventionally, we perform standard resection (SR) in a piecemeal manner. However, this results in tumour fragmentation and possible tumour re-implantation. Moreover, residual disease is present in up to 33.3% of cases following a ‘complete tumour resection’ during the first SR [2]. En bloc resection (EBR) has been proposed as an alternative method in resecting NMIBC [3]. In our series, the successful EBR rate was 98.6%, with clear circumferential and deep resection margins being achieved in all of them [4]. This is potentially a simple yet superior surgical technique in treating NMIBC.    Aims and hypothesis This study aims to compare between SR and EBR in treating NMIBC. We hypothesized that, by preventing tumour fragmentation and ensuring complete tumour resection, EBR could reduce disease recurrence as compared to SR [5].    Methods  This is a prospective, multi-centre randomised controlled trial involving 11 centres, comparing SR and EBR in treating NMIBC. All consecutive patients who are diagnosed with bladder tumours would be screened for study eligibility and, if passed, recruited. The primary outcome is the 1-year recurrence rate. Secondary outcomes include the following: detrusor muscle sampling rate, occurrence of obturator reflex, operative time, rate of immediate post-operative mitomycin C instillation, hospital stay, 30-day complications, any residual or upstaging of disease upon second-look TURBT and 1-year progression rate.    Sample size calculation  Based on previous data [6, 7], assuming a 16.5% difference in the 1-year recurrence rate with a significance level of 0.05 and a power of 80%, 118 patients would be required in each group. Taking into account that 24% of them would have a histological diagnosis other than NMIBC; and assuming a 10% drop-out rate, 174 patients would be required in each group, i.e. 348 patients in total.    Timeline and feasibility  Eleven hospitals are involved in this study. The enrollment period is expected to be 21 months with an estimated number of 1353 potential cases for recruitment. Patients will be followed up for 1 year and the study is expected to complete in 3 years.    Future studies  This study could determine the role of EBR in treating NMIBC. The findings may provide a new standard in resection, of which future adjunctive therapies are to be planned. The observed recurrence pattern may also help to formulate the surveillance cystoscopy protocol following EBR.
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System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • FOR (ANZSRC)

    1112 Oncology and Carcinogenesis

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Urologic Diseases

  • HRCS HC

    Cancer

  • HRCS RAC

    6.4 Surgery

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science