Clinical trial NCT01004211: Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging
Official title: A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Muscle Invasive Bladder Cancer
Keywords: bladder cancer
recurrence
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded.
* All patients will provide a written informed consent prior to the study.
* Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms.

Exclusion Criteria:

* Patients with muscle invasive bladder cancer will be excluded.
* Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.

Primary outcomes:
measure: Recurrence free survival rate
timeFrame: One year
Secondary outcomes:
measure: Detection rate
timeFrame: At the end of enrollment
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: National Institute for Cancer Research (IST)
city: Imperia
country: Italy
facility: Centro Urologico di Eccellenza ASL 1
Study officials:
affiliation: National Institute for Cancer Research, Genoa, Italy
name: Paolo Puppo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.