Transurethral En Bloc Versus Standard Resection of Bladder Tumour

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: Bipolar transurethral en bloc resection; Device: Bipolar transurethral standard resection

• Registration Number: NCT02993211
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-15
• Study Start: 2017-04-18
• Primary Completion: 2022-02-11
• Status Verified: 2022-06
• Study Completion: 2022-06-09
• Last Update Submitted: 2022-06-24
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Age ≥ 18 years old with informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
En bloc resection	Bipolar transurethral en bloc resection	For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.
Standard resection	Bipolar transurethral standard resection	For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.

Primary Outcome Measures

Name	Time	Method
One-year recurrence rate	One year after the allocated treatment	Rate of disease recurrence one year after the operation

Secondary Outcome Measures

Name	Time	Method
Occurrence of obturator reflex	Intra-operative	Number of participants with obturator reflex encountered by the operating surgeon during the operation
Rate of mitomycin C instillation	One day after the allocated treatment	Rate of mitomycin C instillation given after the operation
Upstaging of disease upon second look transurethral resection surgery	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.
Detrusor muscle sampling rate	One week after the allocated treatment	Rate of presence of detrusor muscle in the pathological specimen
Operative time	Immediately post-operative	Duration of operation
30-day complications	Thirty days after the allocated treatment	Complications which occur within 30 days after the operation
Residual disease upon second look transurethral resection surgery	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.
Hospital stay	Three days after the allocated treatment	Patients undergoing transurethral resection surgery have an average hospital stay of three days.
One-year progression rate	One year after the allocated treatment	Rate of disease progression one year after the operation

Trial Locations

Locations (13)

North District Hospital; 🇭🇰 Hong Kong, Hong Kong

Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong

Caritas Medical Centre; 🇭🇰 Hong Kong, Hong Kong

Kwong Wah Hospital; 🇭🇰 Hong Kong, Hong Kong

Tseung Kwan O Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Princess Margaret Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Elizabeth Hospital; 🇭🇰 Hong Kong, Hong Kong

Our Lady of Maryknoll Hospital; 🇭🇰 Hong Kong, Hong Kong

Pok Oi Hospital; 🇭🇰 Hong Kong, Hong Kong

United Christian Hospital; 🇭🇰 Hong Kong, Hong Kong