Bladder Cancer Clinical Trial
Official title:
The Global En Bloc Resection of Bladder Tumour Registry
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients >=18 years old with informed consent - Presence of bladder tumour undergoing transurethral ERBT Exclusion Criteria: - Presence or previous history of upper tract urothelial carcinoma - Presence of other active malignancy - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Hong Kong | North District Hospital | Hong Kong | |
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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. — View Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — 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
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. — 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. doi: 10.1097/01.ju.0000070437.14275.e0. — View Citation
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. — View Citation
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. — View Citation
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. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The complete tumour resection rate | Complete tumour resection refers to successful ERBT with negative circumferential and deep resection margins. | One weeks after the surgery | |
Primary | Recurrence-free survival for NMIBC | Recurrence-free survival for patients with non-muscle-invasive bladder cancer | Every 3 months for the first two years, and then every 6 months for the next three years. | |
Secondary | Proper staging rate for NMIBC | The proper staging rate for NMIBC is defined as the absence of any upstaging of the T-stage upon second-look TURBT or radical surgery, in patients who have NMIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen. | Seven weeks after the operation | |
Secondary | Proper staging rate for MIBC | The proper staging for MIBC is defined as the detection of MIBC upon the first En bloc resection, in all patients who have a definitive histological diagnosis of MIBC upon second-look TURBT or radical surgery. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen | Seven weeks after the operation | |
Secondary | Complete tumour resection rate for MIBC | The complete tumour resection rate for MIBC is defined as the absence of any malignancy upon second-look TURBT or radical surgery, in patients who have MIBC upon the first ERBT. Second look transurethral resection surgery or radical surgery are expected to perform within six weeks after the first operation and one more week is allowed for histological assessment of the second operative specimen | Seven weeks after the operation | |
Secondary | Successful ERBT rate | Technical success rate of en bloc resection | Immediately post-operative | |
Secondary | Negative circumferential resection margin rate | Rate of negative circumferential resection margin of the en bloc resection pathological specimen | One week after the operation | |
Secondary | Negative deep resection margin rate | Rate of negative deep resection margin of the en bloc resection pathological specimen | One week after the operation | |
Secondary | Detrusor muscle sampling rate | Rate of presence of detrusor muscle in the en bloc resection pathological specimen | One week after the operation | |
Secondary | Occurrence of obturator reflex | Number of participants with obturator reflex encountered by the operating surgeon during the en bloc resection operation | Intra-operative | |
Secondary | Operative time | Duration of operation | Immediately post-operative | |
Secondary | Rate of mitomycin C instillation | One day after the surgery | Immediately post-operative | |
Secondary | Duration of bladder irrigation | Duration of bladder irrigation. Patients undergoing transurethral resection surgery have an average hospital stay of three days. Bladder irrigation is always stopped before the patient is discharged | Three days after the operation | |
Secondary | Hospital stay | Patients undergoing transurethral resection surgery have an average hospital stay of three days. | Three days after the operation | |
Secondary | 30-day complications | The 30-day complications will be graded according to the Clavien-Dindo classification | Thirty days after the operation | |
Secondary | Progression-free survival | Progression-free survival | Every 3 months for the first two years, and then every 6 months for the next three years. |
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