Trial Outcomes & Findings for Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer (NCT NCT01180478)
NCT ID: NCT01180478
Last Updated: 2018-04-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
965 participants
Primary outcome timeframe
1 year after treatment
Results posted on
2018-04-25
Participant Flow
Participant milestones
| Measure |
Narrow Band Imaging
Narrow Band Imaging (NBI)
Narrow Band Imaging: Narrow Band Imaging
|
White Light Trans Urethral Resection
White Light Trans Urethral Resection
White Light: White Light Cystoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
484
|
481
|
|
Overall Study
COMPLETED
|
303
|
293
|
|
Overall Study
NOT COMPLETED
|
181
|
188
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Study of Narrow Band Imaging Versus White Light Resection in Patients With Bladder Tumors/Cancer
Baseline characteristics by cohort
| Measure |
Narrow Band Imaging
n=484 Participants
Narrow Band Imaging (NBI)
Narrow Band Imaging: Narrow Band Imaging
|
White Light Trans Urethral Resection
n=481 Participants
White Light Trans Urethral Resection
White Light: White Light Cystoscopy
|
Total
n=965 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
66.7 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
66.24 years
STANDARD_DEVIATION 12.41 • n=27 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
390 Participants
n=93 Participants
|
383 Participants
n=4 Participants
|
773 Participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
52 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
41 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
51 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Region of Enrollment
Hong Kong
|
23 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Region of Enrollment
India
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
3 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
97 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
172 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
43 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Region of Enrollment
Norway
|
13 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
29 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Region of Enrollment
Russia
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
41 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
38 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Region of Enrollment
United Arab Emirates
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 year after treatmentThe 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.
Outcome measures
| Measure |
Narrow Band Imaging
n=484 Participants
|
White Light
n=481 Participants
|
|---|---|---|
|
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
|
109 Participants
|
SECONDARY outcome
Timeframe: 3 months after treatmentOutcome measures
| Measure |
Narrow Band Imaging
n=484 Participants
|
White Light
n=481 Participants
|
|---|---|---|
|
Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection
|
59 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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
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
Outcome measures
| Measure |
Narrow Band Imaging
n=482 Participants
|
White Light
n=478 Participants
|
|---|---|---|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
None
|
415 Participants
|
429 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
I
|
28 Participants
|
19 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
II
|
23 Participants
|
21 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
IIIA
|
11 Participants
|
4 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
IIIB
|
3 Participants
|
5 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
IVA
|
0 Participants
|
0 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
IVB
|
0 Participants
|
0 Participants
|
|
Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
V
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: peri-operativePopulation: The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported
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.
Outcome measures
| Measure |
Narrow Band Imaging
n=484 Participants
|
White Light
n=481 Participants
|
|---|---|---|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Bleeding
|
36 Participants
|
27 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Fever
|
9 Participants
|
7 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
UTI
|
8 Participants
|
10 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Bladder cramps
|
19 Participants
|
10 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
DVT
|
0 Participants
|
0 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
CVA/TIA
|
2 Participants
|
0 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Lung embolism
|
0 Participants
|
0 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Sepsis
|
2 Participants
|
0 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Acute Abdomen
|
1 Participants
|
1 Participants
|
|
Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Other perioperative complication
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Until 135 daysPopulation: 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.
Outcome measures
| Measure |
Narrow Band Imaging
n=61 Participants
|
White Light
n=70 Participants
|
|---|---|---|
|
Recurrence Rate Related to Additional Treatment Following TURB.
|
27 participants
|
27 participants
|
Adverse Events
Narrow Band Imaging
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
White Light Trans Urethral Resection
Serious events: 27 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Narrow Band Imaging
n=484 participants at risk
Narrow Band Imaging (NBI)
Narrow Band Imaging: Narrow Band Imaging
|
White Light Trans Urethral Resection
n=481 participants at risk
White Light Trans Urethral Resection
White Light: White Light Cystoscopy
|
|---|---|---|
|
Infections and infestations
urinary tract infection
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Hepatobiliary disorders
galbladder carcinoma
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
radical cystectomy
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Respiratory, thoracic and mediastinal disorders
lung adenocarcinoma
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
hydronephrosis
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Musculoskeletal and connective tissue disorders
hip's fracture
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Vascular disorders
cardiogenic embolism
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
transurethral urethrotomy
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Infections and infestations
campylobacter colitis
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Gastrointestinal disorders
rectorrhagia
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Gastrointestinal disorders
patient died of intestinal obstruction
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Respiratory, thoracic and mediastinal disorders
patient died of chest infection
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
General disorders
patient died of unknown cause
|
0.41%
2/484
Only Serious Adverse Events were monitored
|
0.42%
2/481
Only Serious Adverse Events were monitored
|
|
Vascular disorders
cerebrovascular attack
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Injury, poisoning and procedural complications
patient died by car accident
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Cardiac disorders
patient died of cardiac arrest
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
patient died of bladder cancer
|
0.41%
2/484
Only Serious Adverse Events were monitored
|
1.0%
5/481
Only Serious Adverse Events were monitored
|
|
Injury, poisoning and procedural complications
obturator kick
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
patient died by renal insuffiency and prostate cancer
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Respiratory, thoracic and mediastinal disorders
acute exacerbation of COPD
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Gastrointestinal disorders
herniainguinalis
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Respiratory, thoracic and mediastinal disorders
patient died of respiratory insuffiency by bilaterial pneumonia
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Vascular disorders
pulmonary embolism
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Infections and infestations
acute prostatitis
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
patient died of another neoplasm
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
transurethral resection prostate
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
transurethral urinary resection
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
patient died of kidney failure
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Cardiac disorders
patient died of heart attack
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Injury, poisoning and procedural complications
urethral injury occurred at time of TUR
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
patient died of cancer
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Infections and infestations
infection of unknown origin
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
General disorders
euthanasia
|
0.00%
0/484
Only Serious Adverse Events were monitored
|
0.21%
1/481
Only Serious Adverse Events were monitored
|
|
Cardiac disorders
patient died of asystolia
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Hepatobiliary disorders
patient died of biliary tract cancer
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Gastrointestinal disorders
patient died of pancreas cancer
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Infections and infestations
patient died of septicaemia
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
|
Renal and urinary disorders
radical cystectomy + bricker
|
0.21%
1/484
Only Serious Adverse Events were monitored
|
0.00%
0/481
Only Serious Adverse Events were monitored
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place