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NCT Number: NCT04934540

The Global En Bloc Resection of Bladder Tumour Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North District Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

En bloc resection of bladder tumour

Procedure

En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece

Primary outcomes

  1. The complete tumour resection rate

    Time frame: One weeks after the surgery

    Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins.

  2. Recurrence-free survival for NMIBC

    Time frame: 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 outcomes

  1. Proper staging rate for NMIBC

    Time frame: 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.

  2. Proper staging rate for MIBC

    Time frame: 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

  3. Complete tumour resection rate for MIBC

    Time frame: 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

  4. Successful ERBT rate

    Time frame: Immediately post-operative

    Technical success rate of en bloc resection

  5. Negative circumferential resection margin rate

    Time frame: One week after the operation

    Rate of negative circumferential resection margin of the en bloc resection pathological specimen

  6. Negative deep resection margin rate

    Time frame: One week after the operation

    Rate of negative deep resection margin of the en bloc resection pathological specimen

  7. Detrusor muscle sampling rate

    Time frame: One week after the operation

    Rate of presence of detrusor muscle in the en bloc resection pathological specimen

  8. Occurrence of obturator reflex

    Time frame: Intra-operative

    Number of participants with obturator reflex encountered by the operating surgeon during the en bloc resection operation

  9. Operative time

    Time frame: Immediately post-operative

    Duration of operation

  10. Rate of mitomycin C instillation

    Time frame: Immediately post-operative

    One day after the surgery

  11. Duration of bladder irrigation

    Time frame: 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

  12. Hospital stay

    Time frame: Three days after the operation

    Patients undergoing transurethral resection surgery have an average hospital stay of three days.

  13. 30-day complications

    Time frame: Thirty days after the operation

    The 30-day complications will be graded according to the Clavien-Dindo classification

  14. Progression-free survival

    Time frame: Every 3 months for the first two years, and then every 6 months for the next three years.

    Progression-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jeremy YC TEOH, FRCS(Ed) MBBS

CONTACT

[email protected]

852-35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2021
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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