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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer | Device: White Light Device: Narrow Band Imaging | Not Applicable |
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 |

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 |
- 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.
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Study Director: | Jean de la Rosette, MD | AMC University Hospital |
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 |
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 |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |