Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer

Clinical Research Office of the Endourological Society

Status

Completed

Conditions

Bladder Cancer

Treatments

Device: White Light

Device: Narrow Band Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01180478

10-004660

Details and patient eligibility

About

The purpose of this study is to compare the recurrence rate at 1 year following Narrow Band Imaging and trans-urethral resection of bladder tumor with White Light and TURB in patients with non-muscle invasive bladder cancer.

Full description

Currently bladder tumors are diagnosed visually with standard cystoscopy that uses white light, or light that is generated encompassing the entire visual spectrum. Some tumors such as carcinoma in situ may not be visible using white light and require patients to undergo random bladder biopsies in order to find the cancer. Recently the development of photodynamic agents have been shown to enhance these procedures to accomplish better resection and identify over-looked tumors. However, these methods often require the instillation of dyes into the bladder as well as specialized cystoscopes. Narrow band imaging (NBI) is now available which uses a special filter to limit the light to only certain wavelengths which allows the identification of areas of increased vascularity or abnormalities without the need for dyes. NBI has been investigated in gastro-intestinal disease and found to be beneficial. Early reports in urology suggest that this technology may reduce the number of tumors that are missed which could impact the recurrence rate of bladder tumors, but this is not known at this time.

Enrollment

965 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for treatment of primary or recurrent non-muscle invasive bladder cancer
Patients greater than 18 years of age
No tumors in the upper tract (kidneys or ureters)
No previous pelvic radiation

Exclusion criteria

Gross hematuria at the time of resection making visualization with NBI not possible
Participation in other clinical studies with investigations drugs concurrently or within 30 days.
Pregnancy
Conditions associated with a risk of poor compliance or unwilling to follow up