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NCT Number: NCT02993211

Transurethral En Bloc Versus Standard Resection of Bladder Tumour

Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caritas Medical Centre, Hong Kong

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About this study

Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. In Hong Kong, more than 400 new cases of bladder cancer are diagnosed every year. It is a common and important disease which carries a significant burden to the health medical system.

For patients who are diagnosed to have bladder tumours upon flexible cystoscopy, transurethral resection of bladder tumour (TURBT) should be offered. Being a minimally invasive procedure, it has become the standard for the initial management of bladder cancer. This operation aims to ascertain the diagnosis, to correctly stage the tumour (T-stage) and to cure the disease in the case of non-muscle-invasive bladder cancer (NMIBC). However, in a combined analysis of 2,596 patents from 7 randomised controlled trials in patients with NMIBC, it was shown that 1-year recurrence rate ranged from 15-61%, and 5-year recurrence rate ranged from 31-78%. Despite possible complete tumour resection during TURBT, the oncological control of NMIBC is far from satisfactory.

There are two main problems with the conventional standard resection (SR) procedure. First, the bladder tumour is resected in a piecemeal manner. This results in tumour fragmentation and floating tumour cells inside the bladder. The tumour cells may re-implant on to the bladder wall and lead to early disease recurrence. Second, 'complete tumour resection' is often determined by endoscopic vision only. Due to the inherited nature of piecemeal resection, it is not possible to assess the resection margin by histological means. The charring effect to the resection bed may also hinder the judgement of a 'complete tumour resection'. Routine second-look TURBT has been advocated for selected patients (Any presence of T1 disease, G3 disease, or any absence of detrusor muscle in the first TURBT specimen) even after a 'complete tumour resection' during the first TURBT. 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. These results highlighted the limitations of TURBT in ascertaining complete tumour resection.

Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old with informed consent

Exclusion criteria

  • Bladder tumour base with maximal dimension of >3cm (Anticipated difficulty in retrieving the specimen en bloc)
  • Bladder tumour detected during intravesical BCG therapy (BCG failure warrants more aggressive treatment, i.e. radical cystectomy)
  • Histological diagnosis other than NMIBC
  • Presence or prior history of upper urinary tract malignancy
  • ECOG performance status ≥ 3 (Confined to bed or chair more than 50% of waking hours)
  • ASA III or above (Patient with severe systemic disease)
  • History of bleeding disorder or use of anti-coagulants
  • Pregnancy
  • Presence of other active malignancy
  • Life expectancy of less than one year

Treatment and study plan

Bipolar transurethral standard resection

Device

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Bipolar transurethral en bloc resection

Device

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Primary outcomes

  1. One-year recurrence rate

    Time frame: One year after the allocated treatment

    Rate of disease recurrence one year after the operation

Secondary outcomes

  1. Detrusor muscle sampling rate

    Time frame: One week after the allocated treatment

    Rate of presence of detrusor muscle in the pathological specimen

  2. Occurrence of obturator reflex

    Time frame: Intra-operative

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

  3. Operative time

    Time frame: Immediately post-operative

    Duration of operation

  4. Rate of mitomycin C instillation

    Time frame: One day after the allocated treatment

    Rate of mitomycin C instillation given after the operation

  5. Hospital stay

    Time frame: Three days after the allocated treatment

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

  6. 30-day complications

    Time frame: Thirty days after the allocated treatment

    Complications which occur within 30 days after the operation

  7. Residual disease upon second look transurethral resection surgery

    Time frame: Seven weeks after the allocated treatment

    Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Residual disease is measured by the number of participants with the presence of urothelial carcinoma in the second look transurethral resection specimen.

  8. Upstaging of disease upon second look transurethral resection surgery

    Time frame: Seven weeks after the allocated treatment

    Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Upstaging of disease is measured by the number of participants with upstaging of disease from non-muscle-invasive bladder cancer to muscle-invasive bladder cancer in the second look transurethral resection specimen.

  9. One-year progression rate

    Time frame: One year after the allocated treatment

    Rate of disease progression one year after the operation

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Caritas Medical Centre, Hong Kong
  • Kwong Wah Hospital
  • North District Hospital
  • Our Lady of Maryknoll Hospital
  • Pok Oi Hospital
  • Princess Margaret Hospital, Hong Kong
  • Queen Elizabeth Hospital, Hong Kong
  • The University of Hong Kong
  • Tseung Kwan O Hospital, Hong Kong
  • Tuen Mun Hospital
  • Tung Wah Hospital
  • United Christian Hospital

Registry information

Official study title

Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2016
Registry last updated
Jun 29, 2022

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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