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Transurethral En Bloc Versus Standard Resection of Bladder Tumour

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ClinicalTrials.gov Identifier: NCT02993211
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Kwong Wah Hospital
North District Hospital
Our Lady of Maryknoll Hospital
Pok Oi Hospital
The University of Hong Kong
Tseung Kwan O Hospital
Tuen Mun Hospital
Tung Wah Hospital
United Christian Hospital
Princess Margaret Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Information provided by (Responsible Party):
Jeremy Yuen Chun TEOH, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: Bipolar transurethral standard resection Device: Bipolar transurethral en bloc resection Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Standard resection
For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.
Device: Bipolar transurethral standard resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Experimental: En bloc resection
For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.
Device: Bipolar transurethral en bloc resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)




Primary Outcome Measures :
  1. One-year recurrence rate [ Time Frame: One year after the allocated treatment ]
    Rate of disease recurrence one year after the operation


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993211


Contacts
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Contact: Jeremy YC Teoh, MBBS +852 3505 2625 jeremyteoh@surgery.cuhk.edu.hk
Contact: Jenny SY Yip, MPH +852 3505 1663 siuying@surgery.cuhk.edu.hk

Locations
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Hong Kong
Caritas Medical Centre Recruiting
Hong Kong, Hong Kong
Contact: Yi Chiu         
Principal Investigator: Yi Chiu         
Sub-Investigator: Man-Chung Law         
Sub-Investigator: Chun-Ki Chan         
Sub-Investigator: Vincent YK Poon         
Sub-Investigator: Chi-Ho Ip         
Kwong Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wing-Hong Chu         
Principal Investigator: Wing-Hong Chu         
Sub-Investigator: Chak-Lam Cho         
Sub-Investigator: Kwun-Wai Chan         
Sub-Investigator: In-Chak Law         
Sub-Investigator: Clarence LH Leung         
North District Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ho-Man Tam         
Principal Investigator: Ho-Man Tam         
Sub-Investigator: Jeremy YC Teoh         
Sub-Investigator: Peter KF Chiu         
Sub-Investigator: Hon-Ming Wong         
Sub-Investigator: Joseph KM Li         
Our Lady of Maryknoll Hospital Recruiting
Hong Kong, Hong Kong
Contact: Chak-Lam Cho         
Principal Investigator: Chak-Lam Cho         
Sub-Investigator: Wing-Hong Chu         
Sub-Investigator: Kwun-Wai Chan         
Sub-Investigator: In-Chak Law         
Sub-Investigator: Clarence LH Leung         
Pok Oi Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tsz-Yeung Chan         
Principal Investigator: Tsz-Yeung Chan         
Sub-Investigator: Sau-Kwan Chu         
Sub-Investigator: Chi-Wai Man         
Sub-Investigator: Cheung-Hing Cheng         
Sub-Investigator: Chris YK Lee         
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Jeremy YC Teoh         
Principal Investigator: Jeremy YC Teoh         
Sub-Investigator: Eddie SY Chan         
Sub-Investigator: Peter KF Chiu         
Sub-Investigator: Chi-Fai Ng         
Sub-Investigator: Chi-Hang Yee         
Sub-Investigator: Hon-Ming Wong         
Sub-Investigator: Joseph KM Li         
Princess Margaret Hospital Recruiting
Hong Kong, Hong Kong
Contact: Yi Chiu         
Principal Investigator: Yi Chiu         
Sub-Investigator: Man-Chung Law         
Sub-Investigator: Chun-Ki Chan         
Sub-Investigator: Vincent YK Poon         
Sub-Investigator: Chi-Ho Ip         
Queen Elizabeth Hospital Recruiting
Hong Kong, Hong Kong
Contact: Trevor CF Li         
Principal Investigator: Trevor CF Li         
Sub-Investigator: Chi-Man Ng         
Sub-Investigator: Chung-Ting Pun         
Sub-Investigator: Tsz-Leung Ng         
Sub-Investigator: Chi-Fai Kan         
Sub-Investigator: Ho-Yin Ngai         
Sub-Investigator: Wai-Man Kan         
Sub-Investigator: Wing-Hang Au         
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Brian SH Ho         
Principal Investigator: Brian SH Ho         
Sub-Investigator: Chiu-Fung Tsang         
Sub-Investigator: Ming-Kwong Yiu         
Sub-Investigator: Terence CT Lai         
Sub-Investigator: Wai-Kit Ma         
Sub-Investigator: Ada TL Ng         
Sub-Investigator: Charles KW Wong         
Sub-Investigator: James HL Tsu         
Tseung Kwan O Hospital Recruiting
Hong Kong, Hong Kong
Contact: Bryan KC Cheng         
Principal Investigator: Bryan KC Cheng         
Sub-Investigator: Wilson HC Chan         
Sub-Investigator: Kin-Man Lam         
Tuen Mun Hospital Recruiting
Hong Kong, Hong Kong
Contact: Sau-Kwan Chu         
Principal Investigator: Sau-Kwan Chu         
Sub-Investigator: Chi-Wai Man         
Sub-Investigator: Tsz-Yeung Chan         
Sub-Investigator: Cheung-Hing Cheng         
Sub-Investigator: Chris YK Lee         
Tung Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Chiu-Fung Tsang         
Principal Investigator: Chiu-Fung Tsang         
Sub-Investigator: Brian SH Ho         
Sub-Investigator: Ming-Kwong Yiu         
Sub-Investigator: Terence CT Lai         
Sub-Investigator: Wai-Kit Ma         
Sub-Investigator: Ada TL Ng         
Sub-Investigator: Charles KW Wong         
Sub-Investigator: James HL Tsu         
United Christian Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wilson HC Chan         
Principal Investigator: Wilson HC Chan         
Sub-Investigator: Bryan KC Cheng         
Sub-Investigator: Hing-Shing So         
Sponsors and Collaborators
Chinese University of Hong Kong
Kwong Wah Hospital
North District Hospital
Our Lady of Maryknoll Hospital
Pok Oi Hospital
The University of Hong Kong
Tseung Kwan O Hospital
Tuen Mun Hospital
Tung Wah Hospital
United Christian Hospital
Princess Margaret Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Investigators
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Principal Investigator: Jeremy YC Teoh, MBBS Chinese University of Hong Kong

Publications:

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Responsible Party: Jeremy Yuen Chun TEOH, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02993211     History of Changes
Other Study ID Numbers: CRE Ref. No. 2016.553
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Yuen Chun TEOH, Chinese University of Hong Kong:
Bladder cancer
Transurethral resection
En bloc resection
TURBT
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases