Clinical trial NCT01180478: Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Urothelial carcinoma
Stage pTa or pT1
NMIBC Ta/T1
Narrow Band Imaging
White Light Cystoscopy
Transurethral resection
Superficial bladder tumor
Positive urine cytology
Lead sponsor: Clinical Research Office of the Endourological Society
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection
timeFrame: 3 months after treatment
measure: Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
timeFrame: 30 days
measure: Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
timeFrame: peri-operative
measure: Recurrence Rate Related to Additional Treatment Following TURB.
timeFrame: Until 135 days
Other outcomes:
Locations:
Study officials:
affiliation: AMC University Hospital
name: Jean de la Rosette, MD
role: STUDY_DIRECTOR
References: