Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).
Condition: Bladder Cancer
Intervention:
- Device: Bipolar transurethral standard resection
- Device: Bipolar transurethral en bloc resection
Purpose: 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.
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02993211
Sponsor: Chinese University of Hong Kong
Primary Outcome Measures:
- Measure: One-year recurrence rate
- Time Frame: One year after the allocated treatment
- Safety Issue:
Secondary Outcome Measures:
- Measure: Detrusor muscle sampling rate
- Time Frame: One week after the allocated treatment
- Safety Issue:
- Measure: Occurrence of obturator reflex
- Time Frame: Intra-operative
- Safety Issue:
- Measure: Operative time
- Time Frame: Immediately post-operative
- Safety Issue:
- Measure: Rate of mitomycin C instillation
- Time Frame: One day after the allocated treatment
- Safety Issue:
- Measure: Hospital stay
- Time Frame: Three days after the allocated treatment
- Safety Issue:
- Measure: 30-day complications
- Time Frame: Thirty days after the allocated treatment
- Safety Issue:
- Measure: Residual disease upon second look transurethral resection surgery
- Time Frame: Seven weeks after the allocated treatment
- Safety Issue:
- Measure: Upstaging of disease upon second look transurethral resection surgery
- Time Frame: Seven weeks after the allocated treatment
- Safety Issue:
- Measure: One-year progression rate
- Time Frame: One year after the allocated treatment
- Safety Issue:
Estimated Enrollment: 350
Study Start Date: April 18, 2017
Phase: Phase 3
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
Inclusion Criteria:
- Age ≥ 18 years old with informed consent
Exclusion Criteria:
- 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
Contact:
- Jeremy YC Teoh, MBBS
- +852 3505 2625
Locations:
- Caritas Medical Centre
- Hong Kong Hong Kong
- Kwong Wah Hospital
- Hong Kong Hong Kong
- North District Hospital
- Hong Kong Hong Kong
- Our Lady of Maryknoll Hospital
- Hong Kong Hong Kong
- Pok Oi Hospital
- Hong Kong Hong Kong
- Prince of Wales Hospital
- Hong Kong Hong Kong
- Princess Margaret Hospital
- Hong Kong Hong Kong
- Queen Elizabeth Hospital
- Hong Kong Hong Kong
- Queen Mary Hospital
- Hong Kong Hong Kong
- Tseung Kwan O Hospital
- Hong Kong Hong Kong
- Tuen Mun Hospital
- Hong Kong Hong Kong
- Tung Wah Hospital
- Hong Kong Hong Kong
- United Christian Hospital
- Hong Kong Hong Kong
View trial on ClinicalTrials.gov