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

NCT ID: NCT01180478

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 965 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed 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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Narrow Band Imaging

Narrow Band Imaging (NBI)

Group Type: OTHER

Narrow Band Imaging

Intervention Type: DEVICE

Narrow Band Imaging

White Light Trans Urethral Resection

White Light Trans Urethral Resection

Group Type: OTHER

White Light

Intervention Type: DEVICE

White Light Cystoscopy

Interventions

White Light

White Light Cystoscopy

Intervention Type: DEVICE

Narrow Band Imaging

Narrow Band Imaging

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Research Office of the Endourological Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean de la Rosette, MD

Role: STUDY_DIRECTOR

AMC University Hospital

Other Identifiers

10-004660

Identifier Type: -

Identifier Source: org_study_id