deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02993211

Transurethral En Bloc Versus Standard Resection of Bladder Tumour

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

Sponsor: Caritas Medical Centre, Hong Kong

Conditions Bladder Cancer
Updated 16 times since 2017 Last updated: Jun 24, 2022 Started: Apr 18, 2017 Primary completion: Feb 11, 2022 Completion: Jun 9, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Bladder Cancer and is currently completed. Caritas Medical Centre, Hong Kong leads this study, which shows 16 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~May 2018 · 11 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2020 · 13 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jul 2022 · 17 months · monthly snapshot~Jul 2022 – ~Feb 2023 · 7 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshot

Change History

16 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed NA

  2. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  3. Feb 2023 — Jul 2024 [monthly]

    Completed NA

  4. Jul 2022 — Feb 2023 [monthly]

    Completed NA

    Status: RecruitingCompleted · Phase: PHASE3NA

  5. Feb 2021 — Jul 2022 [monthly]

    Recruiting PHASE3

Show 11 earlier versions
  1. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  2. Feb 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  3. Jan 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

  4. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  5. Jul 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  6. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  7. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  8. Jun 2017 — May 2018 [monthly]

    Recruiting PHASE3

  9. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  10. Feb 2017 — May 2017 [monthly]

    Not Yet Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Caritas Medical Centre, Hong Kong
  • Chinese University of 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
Data source: Chinese University of Hong Kong

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations