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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01180478
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society

Tracking Information
First Submitted Date  ICMJE August 10, 2010
First Posted Date  ICMJE August 12, 2010
Results First Submitted Date  ICMJE August 10, 2017
Results First Posted Date  ICMJE April 25, 2018
Last Update Posted Date April 25, 2018
Study Start Date  ICMJE August 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
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. [ Time Frame: 1 year after treatment ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
Compare 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection [ Time Frame: 3 months after treatment ]
  • Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. [ Time Frame: 30 days ]
    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
  • Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. [ Time Frame: peri-operative ]
    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.
  • Recurrence Rate Related to Additional Treatment Following TURB. [ Time Frame: Until 135 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2010)
  • Persistence/recurrence of tumors at first 3 month follow up after NBI versus WL cystoscopy and tumor resection. [ Time Frame: 3 months after treatment ]
  • Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. [ Time Frame: 30 days ]
  • Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. [ Time Frame: 1 year ]
  • Recurrence rate related to surgeon performing the procedure. [ Time Frame: 1 year ]
  • Recurrence Rate Related to Additional Treatment Following TURB. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • Device: White Light
    White Light Cystoscopy
  • Device: Narrow Band Imaging
    Narrow Band Imaging
Study Arms  ICMJE
  • Narrow Band Imaging
    Narrow Band Imaging (NBI)
    Intervention: Device: Narrow Band Imaging
  • White Light Trans Urethral Resection
    White Light Trans Urethral Resection
    Intervention: Device: White Light
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
965
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2010)
40
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01180478
Other Study ID Numbers  ICMJE 10-004660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Research Office of the Endourological Society
Study Sponsor  ICMJE Clinical Research Office of the Endourological Society
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean de la Rosette, MD AMC University Hospital
PRS Account Clinical Research Office of the Endourological Society
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP