Bladder Cancer
Conditions
Keywords
En bloc resection of bladder tumour
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.
Interventions
PROCEDUREEn bloc resection of bladder tumour
En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece
Sponsors
Chinese University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients \>=18 years old with informed consent * Presence of bladder tumour undergoing transurethral ERBT
Exclusion criteria
* Presence or previous history of upper tract urothelial carcinoma * Presence of other active malignancy * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Hong Kong
Contacts
CONTACTJeremy YC TEOH, FRCS(Ed) MBBS
PRINCIPAL_INVESTIGATORJeremy YC TEOH, FRCS(Ed) MBBS
Chinese University of Hong Kong
Outcome results
None listed