Introduction & Objectives
Conventionally, Standard Resection (SR) is performed by resecting the bladder tumour in a piecemeal manner. En bloc Resection of Bladder Tumour (ERBT) has been proposed as an alternative technique in treating Non-Muscle-Invasive Bladder Cancer (NMIBC).
Materials & Methods
The EB-StaR study is a multi-centre, randomized, phase 3 trial comparing between ERBT and SR. We randomly assigned adults with bladder tumour(s) of ≤3cm to receive ERBT or SR. The primary outcome was 1-year recurrence rate. A modified intention-to-treat analysis on patients with histologically confirmed NMIBC was performed for the study outcomes.
From April 2017 to Dec 2020, a total of 350 patients were recruited and underwent randomization; 276 patients were histologically confirmed to have NMIBC, with 143 patients in the ERBT group and 133 patients in the SR group. Regarding the primary outcome, the 1-year recurrence rates were 28.5% (95% confidence interval, 18.4-37.4%) in the ERBT group, and 38.1% (95% confidence interval, 28.4-46.5%) in the SR group (p=0.007). The 1-year progression rates were 0% in the ERBT group, and 2.6% (95% confidence interval, 0-5.5%) in the SR group (p=0.065). The ERBT group had a longer operative time (33.4±18.5 vs. 24.7±12.9 minutes, p<0.001) than the SR group. Detrusor muscle sampling rates, occurrence of obturator reflex, rates of post-operative mitomycin C instillation, hospital stay, 30-day complications, residual disease and upstaging of disease upon second-look transurethral resection were similar in the two groups.
In patients with NMIBC of ≤3cm, ERBT resulted in a significant reduction in 1-year recurrence rate when compared to SR. (Funded by GRF/ECS, Research Grants Council of Hong Kong, Reference no: 14117421, 14120620 and 24116518; ClinicalTrials.gov number, NCT02993211).