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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Device: White Light Device: Narrow Band Imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 965 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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


  3. 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.

  4. Recurrence Rate Related to Additional Treatment Following TURB. [ Time Frame: Until 135 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180478


Sponsors and Collaborators
Clinical Research Office of the Endourological Society
Investigators
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Study Director: Jean de la Rosette, MD AMC University Hospital
More Information
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Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT01180478    
Other Study ID Numbers: 10-004660
First Posted: August 12, 2010    Key Record Dates
Results First Posted: April 25, 2018
Last Update Posted: April 25, 2018
Last Verified: March 2018
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:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases