Bladder Cancer
Conditions
Keywords
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
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.
Interventions
DEVICEWhite Light
White Light Cystoscopy
DEVICENarrow Band Imaging
Narrow Band Imaging
Sponsors
Clinical Research Office of the Endourological Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | Until 135 days | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Narrow Band Imaging Narrow Band Imaging (NBI)
Narrow Band Imaging: Narrow Band Imaging | 484 |
| White Light Trans Urethral Resection White Light Trans Urethral Resection
White Light: White Light Cystoscopy | 481 |
| Total | 965 |
Baseline characteristics
| Characteristic | Narrow Band Imaging | White Light Trans Urethral Resection | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 12.5 | 66.7 years STANDARD_DEVIATION 12.3 | 66.24 years STANDARD_DEVIATION 12.41 |
| Region of Enrollment Austria | 4 Participants | 8 Participants | 12 Participants |
| Region of Enrollment Canada | 52 Participants | 40 Participants | 92 Participants |
| Region of Enrollment China | 41 Participants | 34 Participants | 75 Participants |
| Region of Enrollment Czechia | 51 Participants | 67 Participants | 118 Participants |
| Region of Enrollment Hong Kong | 23 Participants | 17 Participants | 40 Participants |
| Region of Enrollment India | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment Italy | 3 Participants | 10 Participants | 13 Participants |
| Region of Enrollment Japan | 97 Participants | 75 Participants | 172 Participants |
| Region of Enrollment Netherlands | 41 Participants | 38 Participants | 79 Participants |
| Region of Enrollment Norway | 13 Participants | 16 Participants | 29 Participants |
| Region of Enrollment Romania | 29 Participants | 30 Participants | 59 Participants |
| Region of Enrollment Russia | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment South Korea | 43 Participants | 48 Participants | 91 Participants |
| Region of Enrollment Spain | 9 Participants | 13 Participants | 22 Participants |
| Region of Enrollment Turkey | 38 Participants | 39 Participants | 77 Participants |
| Region of Enrollment United Arab Emirates | 6 Participants | 3 Participants | 9 Participants |
| Region of Enrollment United States | 11 Participants | 17 Participants | 28 Participants |
| Sex: Female, Male Female | 94 Participants | 98 Participants | 192 Participants |
| Sex: Female, Male Male | 390 Participants | 383 Participants | 773 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 25 / 484 | 27 / 481 |
Outcome results
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.
Time frame: 1 year after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Narrow Band Imaging | 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. | 104 Participants |
| White Light | 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. | 109 Participants |
Comparison: The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).p-value: 0.585Log Rank
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Narrow Band Imaging | Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection | 59 Participants |
| White Light | Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection | 61 Participants |
p-value: 0.742Chi-squared
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
Time frame: 30 days
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | None | 415 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | I | 28 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | II | 23 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IIIA | 11 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IIIB | 3 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IVA | 0 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IVB | 0 Participants |
| Narrow Band Imaging | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | V | 2 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | V | 0 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | None | 429 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IIIB | 5 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | I | 19 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IVB | 0 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | II | 21 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IVA | 0 Participants |
| White Light | Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System. | IIIA | 4 Participants |
Comparison: The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.p-value: 0.17Fisher Exact
Secondary
Recurrence Rate Related to Additional Treatment Following TURB.
Time frame: Until 135 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Narrow Band Imaging | Recurrence Rate Related to Additional Treatment Following TURB. | 27 participants |
| White Light | Recurrence Rate Related to Additional Treatment Following TURB. | 27 participants |
p-value: 0.553Chi-squared
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.
Time frame: peri-operative
Population: The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Bleeding | 36 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Fever | 9 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | UTI | 8 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Bladder cramps | 19 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | DVT | 0 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | CVA/TIA | 2 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Lung embolism | 0 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Sepsis | 2 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Acute Abdomen | 1 Participants |
| Narrow Band Imaging | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Other perioperative complication | 9 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Sepsis | 0 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Bleeding | 27 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | CVA/TIA | 0 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Fever | 7 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Other perioperative complication | 13 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | UTI | 10 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Lung embolism | 0 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Bladder cramps | 10 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | Acute Abdomen | 1 Participants |
| White Light | Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment. | DVT | 0 Participants |
Comparison: Comparison of the numbers in 'Bleeding' between NBI and WLp-value: 0.311Chi-squared
Comparison: Comparison of the numbers in 'Fever' between NBI and WLp-value: 0.666Chi-squared
Comparison: Comparison in the number of 'UTI' between NBI and WLp-value: 0.569Chi-squared
Comparison: Comparison in the number of 'Bladder cramps' between NBI and WLp-value: 0.111Chi-squared
Comparison: Comparison in the number of 'DVT' between NBI and WL
Comparison: Comparison in the number of 'CVA/TIA' between NBI and WLp-value: 0.5Fisher Exact
Comparison: Comparison in the number of 'Lung embolism' between NBI and WL
Comparison: Comparison in the number of 'Sepsis' between NBI and WLp-value: 0.5Fisher Exact
Comparison: Comparison in the number of 'Acute Abdomen' between NBI and WLp-value: 1Fisher Exact
Comparison: Comparison in the number of 'Other perioperative complication' between NBI and WLp-value: 0.17Chi-squared