Transurethral En Bloc Versus Standard Resection of Bladder Tumour
NCT ID: NCT02993211
Last Updated: 2022-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2017-04-18
2022-06-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard resection
For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.
Bipolar transurethral standard resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
En bloc resection
For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.
Bipolar transurethral en bloc resection
Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kwong Wah Hospital
OTHER
North District Hospital
OTHER
Our Lady of Maryknoll Hospital
OTHER
Pok Oi Hospital
OTHER
The University of Hong Kong
OTHER
Tseung Kwan O Hospital, Hong Kong
OTHER
Tuen Mun Hospital
OTHER_GOV
Tung Wah Hospital
OTHER
United Christian Hospital
OTHER
Princess Margaret Hospital, Hong Kong
OTHER_GOV
Caritas Medical Centre, Hong Kong
OTHER
Queen Elizabeth Hospital, Hong Kong
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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Jeremy Yuen Chun TEOH
Assistant Professor
Principal Investigators
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Jeremy YC Teoh, MBBS
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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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, , Hong Kong
Countries
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References
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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. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret 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.
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. doi: 10.1097/01.ju.0000070437.14275.e0.
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.
Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmstrom 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. doi: 10.1080/00365590510007793-1.
Lazica DA, Roth S, Brandt AS, Bottcher 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.
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.
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.
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.
Other Identifiers
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CRE Ref. No. 2016.553
Identifier Type: -
Identifier Source: org_study_id
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