Clinical trial NCT02993211: Transurethral En Bloc Versus Standard Resection of Bladder Tumour
Official title: Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder cancer
Transurethral resection
En bloc resection
TURBT
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
name: North District Hospital
name: Our Lady of Maryknoll Hospital
name: Pok Oi Hospital
name: The University of Hong Kong
name: Tseung Kwan O Hospital, Hong Kong
name: Tuen Mun Hospital
name: Tung Wah Hospital
name: United Christian Hospital
name: Princess Margaret Hospital, Hong Kong
name: Caritas Medical Centre, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
First posted: 2016-12-15
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: One-year recurrence rate
timeFrame: One year after the allocated treatment
Secondary outcomes:
measure: Detrusor muscle sampling rate
timeFrame: One week after the allocated treatment
measure: Occurrence of obturator reflex
timeFrame: Intra-operative
measure: Operative time
timeFrame: Immediately post-operative
measure: Rate of mitomycin C instillation
timeFrame: One day after the allocated treatment
measure: Hospital stay
timeFrame: Three days after the allocated treatment
measure: 30-day complications
timeFrame: Thirty days after the allocated treatment
measure: Residual disease upon second look transurethral resection surgery
timeFrame: Seven weeks after the allocated treatment
measure: Upstaging of disease upon second look transurethral resection surgery
timeFrame: Seven weeks after the allocated treatment
measure: One-year progression rate
timeFrame: One year after the allocated treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Caritas Medical Centre
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: North District Hospital
city: Hong Kong
country: Hong Kong
facility: Our Lady of Maryknoll Hospital
city: Hong Kong
country: Hong Kong
facility: Pok Oi Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tseung Kwan O Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Jeremy YC Teoh, MBBS
role: PRINCIPAL_INVESTIGATOR
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