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| Name | Class |
|---|---|
| Kwong Wah Hospital | OTHER |
| North District Hospital | OTHER |
| Our Lady of Maryknoll Hospital | OTHER |
| Pok Oi Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard resection | Active Comparator | For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner. |
|
| En bloc resection | Experimental | For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar transurethral standard resection | Device | Olympus TURis Bipolar HF-resection electrode (Model: WA22306D) |
|
| Measure | Description | Time Frame |
|---|---|---|
| One-year recurrence rate | Rate of disease recurrence one year after the operation | One year after the allocated treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Detrusor muscle sampling rate | Rate of presence of detrusor muscle in the pathological specimen | One week after the allocated treatment |
| Occurrence of obturator reflex | Number of participants with obturator reflex encountered by the operating surgeon during the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy YC Teoh, MBBS | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caritas Medical Centre | Hong Kong | Hong Kong | ||||
| Kwong Wah Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16442208 | Background | 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. | |
| 27324428 |
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| 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 |
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| Bipolar transurethral en bloc resection | Device | Olympus TURis Bipolar HF-resection electrode (Model: WA22306D) |
|
| Intra-operative |
| Operative time | Duration of operation | Immediately post-operative |
| Rate of mitomycin C instillation | Rate of mitomycin C instillation given after the operation | One day after the allocated treatment |
| Hospital stay | Patients undergoing transurethral resection surgery have an average hospital stay of three days. | Three days after the allocated treatment |
| 30-day complications | Complications which occur within 30 days after the operation | Thirty days after the allocated treatment |
| 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 |
| 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 |
| One-year progression rate | Rate of disease progression one year after the operation | One year after the allocated treatment |
| 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 |
| Background |
| 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. |
| 12853793 | Background | 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. |
| 20303646 | Background | 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. |
| 16127800 | Background | 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. |
| 23988813 | Background | 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. |
| 22988482 | Background | 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. |
| 10687997 | Background | 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. |
| 25910478 | Background | 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. |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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