NCT01004211

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Paolo Puppo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Narrow band imaging transurethral resection	Transurethral resection of bladder lesion by mean of narrow band imaging
PROCEDURE	Standard transurethral resection	Transurethral resection of bladder lesion by mean of standard white light

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-10-29
• Last updated: 2018-01-17

Locations

2 sites across 1 country: Italy