The Global En Bloc Resection of Bladder Tumour Registry
- Conditions
- Bladder Cancer
- Interventions
- Procedure: En bloc resection of bladder tumour
- Registration Number
- NCT04934540
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Adult patients >=18 years old with informed consent
- Presence of bladder tumour undergoing transurethral ERBT
- Presence or previous history of upper tract urothelial carcinoma
- Presence of other active malignancy
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing ERBT En bloc resection of bladder tumour Patients who are diagnosed with bladder tumors and planning for ERBT.
- Primary Outcome Measures
Name Time Method The complete tumour resection rate One weeks after the surgery Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins.
Recurrence-free survival for NMIBC 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
- Secondary Outcome Measures
Name Time Method Proper staging rate for NMIBC Seven weeks after the operation The proper staging rate for NMIBC is defined as the absence of any upstaging of the T-stage upon second-look TURBT or radical surgery, in patients who have NMIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen.
Proper staging rate for MIBC Seven weeks after the operation The proper staging for MIBC is defined as the detection of MIBC upon the first En bloc resection, in all patients who have a definitive histological diagnosis of MIBC upon second-look TURBT or radical surgery. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen
Complete tumour resection rate for MIBC Seven weeks after the operation The complete tumour resection rate for MIBC is defined as the absence of any malignancy upon second-look TURBT or radical surgery, in patients who have MIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen
Successful ERBT rate Immediately post-operative Technical success rate of en bloc resection
Negative circumferential resection margin rate One week after the operation Rate of negative circumferential resection margin of the en bloc resection pathological specimen
Negative deep resection margin rate One week after the operation Rate of negative deep resection margin of the en bloc resection pathological specimen
Detrusor muscle sampling rate One week after the operation Rate of presence of detrusor muscle in the en bloc resection pathological specimen
Occurrence of obturator reflex Intra-operative Number of participants with obturator reflex encountered by the operating surgeon during the en bloc resection operation
Operative time Immediately post-operative Duration of operation
Rate of mitomycin C instillation Immediately post-operative One day after the surgery
Duration of bladder irrigation Three days after the operation Duration of bladder irrigation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Bladder irrigation is always stopped before the patient is discharged
Hospital stay Three days after the operation Patients undergoing transurethral resection surgery have an average hospital stay of three days.
30-day complications Thirty days after the operation The 30-day complications will be graded according to the Clavien-Dindo classification
Progression-free survival Every 3 months for the first two years, and then every 6 months for the next three years. Progression-free survival
Trial Locations
- Locations (2)
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
North District Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong