The Global En Bloc Resection of Bladder Tumour Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Global En Bloc Resection of Bladder Tumour Registry

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: En bloc resection of bladder tumour


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing ERBT<br>Patients who are diagnosed with bladder tumors and planning for ERBT. | Procedure: En bloc resection of bladder tumour<br>* En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complete tumour resection rate | Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins. | One weeks after the surgery | 
| Recurrence-free survival for NMIBC | Recurrence-free survival for patients with non-muscle-invasive bladder cancer | Every 3 months for the first two years, and then every 6 months for the next three years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proper staging rate for NMIBC | 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. | Seven weeks after the operation | 
| Proper staging rate for MIBC | 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 | Seven weeks after the operation | 
| Complete tumour resection rate for MIBC | 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 | Seven weeks after the operation | 
| Successful ERBT rate | Technical success rate of en bloc resection | Immediately post-operative | 
| Negative circumferential resection margin rate | Rate of negative circumferential resection margin of the en bloc resection pathological specimen | One week after the operation | 
| Negative deep resection margin rate | Rate of negative deep resection margin of the en bloc resection pathological specimen | One week after the operation | 
| Detrusor muscle sampling rate | Rate of presence of detrusor muscle in the en bloc resection pathological specimen | One week after the operation | 
| Occurrence of obturator reflex | Number of participants with obturator reflex encountered by the operating surgeon during the en bloc resection operation | Intra-operative | 
| Operative time | Duration of operation | Immediately post-operative | 
| Rate of mitomycin C instillation | One day after the surgery | Immediately post-operative | 
| Duration of bladder irrigation | 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 | Three days after the operation | 
| Hospital stay | Patients undergoing transurethral resection surgery have an average hospital stay of three days. | Three days after the operation | 
| 30-day complications | The 30-day complications will be graded according to the Clavien-Dindo classification | Thirty days after the operation | 
| Progression-free survival | Progression-free survival | Every 3 months for the first two years, and then every 6 months for the next three years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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En bloc resection of bladder tumour