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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180478
• Other study ID #: 10-004660
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: March 27, 2018
• Start date: August 2010
• Est. completion date: November 2013

Study information

• Verified date: March 2018
• Source: Clinical Research Office of the Endourological Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 965
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• White Light
White Light Cystoscopy
• Narrow Band Imaging
Narrow Band Imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Office of the Endourological Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.	1 year after treatment
Secondary	Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection		3 months after treatment
Secondary	Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.	Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.; Grade II Requiring pharmacological treatment with drugs other than those allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.; Grade III Requiring surgical, endoscopic or radiological intervention Grade III-a Intervention not under general anaesthesia Grade III-b Intervention under general anaesthesia; Grade IV Life-threatening complication (including CNS complications: brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks) requiring IC/ICU management Grade IV-a Single organ dysfunction (including dialysis) Grade IV-b Multi-organ dysfunction; Grade V Death of a patient	30 days
Secondary	Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.	We looked at different perioperative complications in order to discover peri-operative morbidity after instrumental treatment. The following variables were analyzed: Bleeding, Fever, UTI, Bladder cramps, DVT, CVA/TIA, Lung embolism, Sepsis, Acute Abdomen, and Other perioperative complications.	peri-operative
Secondary	Recurrence Rate Related to Additional Treatment Following TURB.		Until 135 days