Clinical Trials Directory

Trials / Completed

CompletedNCT01180478

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

A Multi-center, International Study to Compare Use of Narrow Band Imaging (NBI) Versus White Light(WL) During Transurethral Resection of Bladder Tumors (TURB) to Asses Recurrence of Bladder Cancer in Terms of Safety and Efficacy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
965 (actual)
Sponsor
Clinical Research Office of the Endourological Society · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEWhite LightWhite Light Cystoscopy
DEVICENarrow Band ImagingNarrow Band Imaging

Timeline

Start date
2010-08-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2010-08-12
Last updated
2018-04-25
Results posted
2018-04-25

Source: ClinicalTrials.gov record NCT01180478. Inclusion in this directory is not an endorsement.