Transurethral En Bloc Versus Standard Resection of Bladder Tumour

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993211
• Other study ID #: CRE Ref. No. 2016.553
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: June 9, 2022

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 9, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Bipolar transurethral standard resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
• Bipolar transurethral en bloc resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Locations

Country	Name	City	State
Hong Kong	Caritas Medical Centre	Hong Kong
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	North District Hospital	Hong Kong
Hong Kong	Our Lady of Maryknoll Hospital	Hong Kong
Hong Kong	Pok Oi 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	Queen Mary Hospital	Hong Kong
Hong Kong	Tseung Kwan O Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (13)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	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, Tuen Mun Hospital, Tung Wah Hospital, United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (9)

Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compérat EM, Hernández V, Kaasinen E, Palou J, Rouprêt M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17. — View Citation

Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19. — View Citation

Grimm MO, Steinhoff C, Simon X, Spiegelhalder P, Ackermann R, Vogeli TA. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol. 2003 Aug;170(2 Pt 1):433-7. — View Citation

Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmström PU. Results of second-look resection after primary resection of T1 tumour of the urinary bladder. Scand J Urol Nephrol. 2005;39(3):206-10. — View Citation

Kramer MW, Rassweiler JJ, Klein J, Martov A, Baykov N, Lusuardi L, Janetschek G, Hurle R, Wolters M, Abbas M, von Klot CA, Leitenberger A, Riedl M, Nagele U, Merseburger AS, Kuczyk MA, Babjuk M, Herrmann TR. En bloc resection of urothelium carcinoma of the bladder (EBRUC): a European multicenter study to compare safety, efficacy, and outcome of laser and electrical en bloc transurethral resection of bladder tumor. World J Urol. 2015 Dec;33(12):1937-43. doi: 10.1007/s00345-015-1568-6. Epub 2015 Apr 25. — View Citation

Lazica DA, Roth S, Brandt AS, Böttcher S, Mathers MJ, Ubrig B. Second transurethral resection after Ta high-grade bladder tumor: a 4.5-year period at a single university center. Urol Int. 2014;92(2):131-5. doi: 10.1159/000353089. Epub 2013 Aug 23. — View Citation

Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. Epub 2006 Jan 17. — View Citation

Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9. — View Citation

Vasdev N, Dominguez-Escrig J, Paez E, Johnson MI, Durkan GC, Thorpe AC. The impact of early re-resection in patients with pT1 high-grade non-muscle invasive bladder cancer. Ecancermedicalscience. 2012;6:269. doi: 10.3332/ecancer.2012.269. Epub 2012 Sep 18. — View Citation

Outcome

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