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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow Band Imaging | Other | Narrow Band Imaging (NBI) |
|
| White Light Trans Urethral Resection | Other | White Light Trans Urethral Resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White Light | Device | White Light Cystoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean de la Rosette, MD | AMC University Hospital | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Narrow Band Imaging | Narrow Band Imaging (NBI) Narrow Band Imaging: Narrow Band Imaging |
| FG001 | White Light Trans Urethral Resection | White Light Trans Urethral Resection White Light: White Light Cystoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Narrow Band Imaging | Narrow Band Imaging (NBI) Narrow Band Imaging: Narrow Band Imaging |
| BG001 | White Light Trans Urethral Resection | White Light Trans Urethral Resection White Light: White Light Cystoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 year after treatment |
|
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Only Serious Adverse Events were monitored
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Narrow Band Imaging | Narrow Band Imaging (NBI) Narrow Band Imaging: Narrow Band Imaging |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | Systematic Assessment |
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There is a possibility of observer bias favouring NBI as a limitation of this single-blind study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. de la Rosette, chairman CROES | CROES | +31 20 5666030 | info@croesoffice.org |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Narrow Band Imaging |
| Device |
Narrow Band Imaging |
|
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 |
| 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 |
| Recurrence Rate Related to Additional Treatment Following TURB. | Until 135 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection | Posted | Count of Participants | Participants | 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 | The Clavien grading of perioperative complications variable contains missings, therefore the valid percentages are presented in the outcome measure data table. The NBI group had 2 missing values, and the WL group had 3 missing values. Therfore, the overall number deviates from 484 and 481. Below shown is a categorical variable with 8 categories | Posted | Count of Participants | Participants | 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. | The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported | Posted | Count of Participants | Participants | peri-operative |
|
|
|
|
| Secondary | Recurrence Rate Related to Additional Treatment Following TURB. | Only 61 of the patients in the total population in the NBI group, and 69 of the patients in the total population of the WL group received a Re-TURBT after initial TURBT (within 135 days). These numbers therefore differ and deviate from the Participant Flow module. | Posted | Number | participants | Until 135 days |
|
|
|
|
| 25 |
| 484 |
| 0 |
| 0 |
| EG001 | White Light Trans Urethral Resection | White Light Trans Urethral Resection White Light: White Light Cystoscopy | 27 | 481 | 0 | 0 |
| galbladder carcinoma | Hepatobiliary disorders | Systematic Assessment |
|
| radical cystectomy | Renal and urinary disorders | Systematic Assessment |
|
| lung adenocarcinoma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hydronephrosis | Renal and urinary disorders | Systematic Assessment |
|
| hip's fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| cardiogenic embolism | Vascular disorders | Systematic Assessment |
|
| transurethral urethrotomy | Renal and urinary disorders | Systematic Assessment |
|
| campylobacter colitis | Infections and infestations | Systematic Assessment |
|
| rectorrhagia | Gastrointestinal disorders | Systematic Assessment |
|
| patient died of intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| patient died of chest infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| patient died of unknown cause | General disorders | Systematic Assessment |
|
| cerebrovascular attack | Vascular disorders | Systematic Assessment |
|
| patient died by car accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| patient died of cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| patient died of bladder cancer | Renal and urinary disorders | Systematic Assessment |
|
| obturator kick | Injury, poisoning and procedural complications | Systematic Assessment |
|
| patient died by renal insuffiency and prostate cancer | Renal and urinary disorders | Systematic Assessment |
|
| acute exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| herniainguinalis | Gastrointestinal disorders | Systematic Assessment |
|
| patient died of respiratory insuffiency by bilaterial pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| acute prostatitis | Infections and infestations | Systematic Assessment |
|
| patient died of another neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| transurethral resection prostate | Renal and urinary disorders | Systematic Assessment |
|
| transurethral urinary resection | Renal and urinary disorders | Systematic Assessment |
|
| patient died of kidney failure | Renal and urinary disorders | Systematic Assessment |
|
| patient died of heart attack | Cardiac disorders | Systematic Assessment |
|
| urethral injury occurred at time of TUR | Injury, poisoning and procedural complications | Systematic Assessment |
|
| patient died of cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
| infection of unknown origin | Infections and infestations | Systematic Assessment |
|
| euthanasia | General disorders | Systematic Assessment |
|
| patient died of asystolia | Cardiac disorders | Systematic Assessment |
|
| patient died of biliary tract cancer | Hepatobiliary disorders | Systematic Assessment |
|
| patient died of pancreas cancer | Gastrointestinal disorders | Systematic Assessment |
|
| patient died of septicaemia | Infections and infestations | Systematic Assessment |
|
| radical cystectomy + bricker | Renal and urinary disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008919 |
| Investigative Techniques |
| II |
|
| IIIA |
|
| IIIB |
|
| IVA |
|
| IVB |
|
| V |
|
| Fever |
|
|
| UTI |
|
|
| Bladder cramps |
|
|
| DVT |
|
|
| CVA/TIA |
|
|
| Lung embolism |
|
|
| Sepsis |
|
|
| Acute Abdomen |
|
|
| Other perioperative complication |
|
|
| 0.666 |
| Superiority or Other |
| Comparison in the number of 'UTI' between NBI and WL | Chi-squared | 0.569 | Superiority or Other |
| Comparison in the number of 'Bladder cramps' between NBI and WL | Chi-squared | 0.111 | Superiority or Other |
| Comparison in the number of 'DVT' between NBI and WL | Superiority or Other | Non of the participants/patients had DVT. Therefore, the p-value is not available |
| Comparison in the number of 'CVA/TIA' between NBI and WL | Fisher Exact | 0.500 | Superiority or Other |
| Comparison in the number of 'Lung embolism' between NBI and WL | Superiority or Other | Non of the participants/patients had a lung embolism. Therefore, no p-value was available |
| Comparison in the number of 'Sepsis' between NBI and WL | Fisher Exact | 0.500 | Superiority or Other |
| Comparison in the number of 'Acute Abdomen' between NBI and WL | Fisher Exact | 1.000 | Superiority or Other |
| Comparison in the number of 'Other perioperative complication' between NBI and WL | Chi-squared | 0.170 | Superiority or Other |