The Global En Bloc Resection of Bladder Tumour Registry

Обзор

The study aims to collect data on ERBT globally in order to clarify its role in the management of bladder cancer over a 5-year observation period.

Подробное описание

Bladder cancer is a prevalent disease globally, and it is the 9th most commonly diagnosed cancer in men worldwide. It has a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. This disease represents a significant burden to the healthcare system.

Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) according to its depth of invasion. Conceptually, NMIBC is amenable to complete resection by transurethral resection of bladder tumour (TURBT) alone, while MIBC requires more aggressive treatment in the form of radical cystectomy. The gold standard in local staging is by histology, and this can be achieved by TURBT. However, conventional TURBT creates charred tissue chips in a piecemeal manner which may hinder pathologists' judgment of the tumour base clearance. 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 following the first TURBT; it has also been shown to improve recurrence-free survival in patients with T1 non-muscle-invasive bladder cancer. In addition, tumour fragmentation and reimplantation may lead to early disease recurrence. All these highlighted the limitations of the conventional TURBT procedure.

Transurethral en bloc resection of bladder tumour (ERBT) represents a novel surgical technique in which the bladder tumour is resected in one piece. Theoretically, ERBT may prevent recurrence by minimizing the risk of tumour reimplantation and ensuring complete resection based on proper histological assessment. Although ERBT has been practised in many centres worldwide, there is a lack of high quality evidence in proving its superiority over conventional TURBT. Also, the optimal indications, best energy modality, the need for routine tumour base biopsy, intravesical chemotherapy, second-look TURBT and the optimal follow-up protocol remain uncertain for this technique. Therefore, there is a need for a well-planned prospective multi-centre study to evaluate the role of ERBT in the management of bladder cancer.

Investigators propose to conduct a prospective, multi-centre, registry study to expedite understanding of ERBT and to establish its role in management of bladder cancer.

Вмешательства

• Процедура En bloc resection of bladder tumour
  En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece

Первичные конечные точки

• The complete tumour resection rate [Срок оценки: One weeks after the surgery]
• Recurrence-free survival for NMIBC [Срок оценки: Every 3 months for the first two years, and then every 6 months for the next three years.]

Вторичные конечные точки (12)

• Proper staging rate for NMIBC [Срок оценки: Seven weeks after the operation]
• Proper staging rate for MIBC [Срок оценки: Seven weeks after the operation]
• Complete tumour resection rate for MIBC [Срок оценки: Seven weeks after the operation]
• Successful ERBT rate [Срок оценки: Immediately post-operative]
• Negative circumferential resection margin rate [Срок оценки: One week after the operation]
• Negative deep resection margin rate [Срок оценки: One week after the operation]
• Detrusor muscle sampling rate [Срок оценки: One week after the operation]
• Occurrence of obturator reflex [Срок оценки: Intra-operative]
• Operative time [Срок оценки: Immediately post-operative]
• Rate of mitomycin C instillation [Срок оценки: Immediately post-operative]
• Duration of bladder irrigation [Срок оценки: Three days after the operation]
• Hospital stay [Срок оценки: Three days after the operation]

Критерии участия

Критерии включения

• Adult patients >=18 years old with informed consent
• Presence of bladder tumour undergoing transurethral ERBT

Критерии исключения

• Presence or previous history of upper tract urothelial carcinoma
• Presence of other active malignancy
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Гонконг · 2 центра

• North District Hospital — Гонконг
• Prince of Wales Hospital — Гонконг

Публикации

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
• 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. PMID 12853793
• 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. PMID 20303646
• 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. PMID 16127800
• 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. PMID 23988813
• 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. PMID 22988482
• Simon R, Eltze E, Schafer KL, Burger H, Semjonow A, Hertle L, Dockhorn-Dworniczak B, Terpe HJ, Bocker W. Cytogenetic analysis of multifocal bladder cancer supports a monoclonal origin and intraepithelial spread of tumor cells. Cancer Res. 2001 Jan 1;61(1):355-62. PMID 11196186
• 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. PMID 27324428

Идентификаторы

NCT: NCT04934540 · CRE 2020.369

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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