The Global En Bloc Resection of Bladder Tumour Registry

Last updated: January 21, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Urothelial Cancer

Treatment

En bloc resection of bladder tumour

Clinical Study ID

NCT04934540
CRE 2020.369
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients >=18 years old with informed consent
  • Presence of bladder tumour undergoing transurethral ERBT

Exclusion

Exclusion Criteria:

  • Presence or previous history of upper tract urothelial carcinoma
  • Presence of other active malignancy
  • Pregnancy

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: En bloc resection of bladder tumour
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • North District Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

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