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To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard transurethral resection | Active Comparator | Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer |
|
| Narrow band imaging transurethral resection | Experimental | The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narrow band imaging transurethral resection | Procedure | Transurethral resection of bladder lesion by mean of narrow band imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival rate | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate | At the end of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Puppo, MD | National Institute for Cancer Research, Genoa, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Cancer Research (IST) | Genoa | 16132 | Italy | |||
| Centro Urologico di Eccellenza ASL 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19549255 | Background | Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Narrow band imaging for detecting residual/recurrent cancerous tissue during second transurethral resection of newly diagnosed non-muscle-invasive high-grade bladder cancer. BJU Int. 2010 Jan;105(2):208-11. doi: 10.1111/j.1464-410X.2009.08701.x. Epub 2009 Jun 22. | |
| 20509796 |
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| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Standard transurethral resection | Procedure | Transurethral resection of bladder lesion by mean of standard white light |
|
| Imperia |
| Italy |
| Naselli A, Introini C, Bertolotto F, Spina B, Puppo P. Feasibility of transurethral resection of bladder lesion performed entirely by means of narrow-band imaging. J Endourol. 2010 Jul;24(7):1131-4. doi: 10.1089/end.2010.0042. |
| 22280855 | Result | Naselli A, Introini C, Timossi L, Spina B, Fontana V, Pezzi R, Germinale F, Bertolotto F, Puppo P. A randomized prospective trial to assess the impact of transurethral resection in narrow band imaging modality on non-muscle-invasive bladder cancer recurrence. Eur Urol. 2012 May;61(5):908-13. doi: 10.1016/j.eururo.2012.01.018. Epub 2012 Jan 20. |
| D014571 |
| Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |