Clinical trial NCT04934540: The Global En Bloc Resection of Bladder Tumour Registry
Official title: The Global En Bloc Resection of Bladder Tumour Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: En bloc resection of bladder tumour
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with bladder tumors upon flexible cystoscopy and planning for ERBT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The complete tumour resection rate
timeFrame: One weeks after the surgery
measure: Recurrence-free survival for NMIBC
timeFrame: Every 3 months for the first two years, and then every 6 months for the next three years.
Secondary outcomes:
measure: Proper staging rate for NMIBC
timeFrame: Seven weeks after the operation
measure: Proper staging rate for MIBC
timeFrame: Seven weeks after the operation
measure: Complete tumour resection rate for MIBC
timeFrame: Seven weeks after the operation
measure: Successful ERBT rate
timeFrame: Immediately post-operative
measure: Negative circumferential resection margin rate
timeFrame: One week after the operation
measure: Negative deep resection margin rate
timeFrame: One week after the operation
measure: Detrusor muscle sampling rate
timeFrame: One week after the operation
measure: Occurrence of obturator reflex
timeFrame: Intra-operative
measure: Operative time
timeFrame: Immediately post-operative
measure: Rate of mitomycin C instillation
timeFrame: Immediately post-operative
measure: Duration of bladder irrigation
timeFrame: Three days after the operation
measure: Hospital stay
timeFrame: Three days after the operation
measure: 30-day complications
timeFrame: Thirty days after the operation
measure: Progression-free survival
timeFrame: Every 3 months for the first two years, and then every 6 months for the next three years.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: North District Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Jeremy YC TEOH, FRCS(Ed) MBBS
role: PRINCIPAL_INVESTIGATOR
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