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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier:
NCT01180478
First received: August 10, 2010
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Device: White Light
Device: Narrow Band Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clinical Research Office of the Endourological Society:

Primary Outcome Measures:
  • 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. [ Time Frame: At 3 months and 1 year after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence/recurrence of tumors at first 3 month follow up after NBI versus WL cystoscopy and tumor resection. [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
  • Peri-operative morbidity (30 days) of TURB between NBI and WL resection using the Clavien system. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Risk factors for the development of peri-operative morbidity after instrumental treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Recurrence rate related to surgeon performing the procedure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Recurrence rate related to additional treatment following TURB. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: August 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Narrow Band Imaging
Narrow Band Imaging (NBI)
Device: Narrow Band Imaging
Narrow Band Imaging
White Light Trans Urethral Resection
White Light Trans Urethral Resection
Device: White Light
White Light Cystoscopy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180478

Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Investigators
Study Director: Jean de la Rosette, MD AMC University Hospital
  More Information

No publications provided

Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT01180478     History of Changes
Other Study ID Numbers: 10-004660
Study First Received: August 10, 2010
Last Updated: March 6, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Clinical Research Office of the Endourological Society:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014