Prospective Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging

Non Muscle Invasive Bladder Cancer Clinical Trial

Official title:

A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004211
• Other study ID #: IST-NBI-2009
• Status: Completed
• Phase: N/A
• First received: October 28, 2009
• Last updated: January 13, 2018
• Start date: August 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2018
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non Muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Narrow band imaging transurethral resection
Transurethral resection of bladder lesion by mean of narrow band imaging
• Standard transurethral resection
Transurethral resection of bladder lesion by mean of standard white light

Locations

Country	Name	City	State
Italy	National Institute for Cancer Research (IST)	Genoa
Italy	Centro Urologico di Eccellenza ASL 1	Imperia

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Puppo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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 recurre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival rate		One year
Secondary	Detection rate		At the end of enrollment