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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
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office of the Endourological Society

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Device: White Light
Device: Narrow Band Imaging
Enrollment 965
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Period Title: Overall Study
Started 484 481
Completed 303 293
Not Completed 181 188
Arm/Group Title Narrow Band Imaging White Light Trans Urethral Resection Total
Hide Arm/Group Description

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Total of all reporting groups
Overall Number of Baseline Participants 484 481 965
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 484 participants 481 participants 965 participants
65.8  (12.5) 66.7  (12.3) 66.24  (12.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 481 participants 965 participants
Female
94
  19.4%
98
  20.4%
192
  19.9%
Male
390
  80.6%
383
  79.6%
773
  80.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 481 participants 965 participants
Austria
4
   0.8%
8
   1.7%
12
   1.2%
Canada
52
  10.7%
40
   8.3%
92
   9.5%
China
41
   8.5%
34
   7.1%
75
   7.8%
Czechia
51
  10.5%
67
  13.9%
118
  12.2%
Hong Kong
23
   4.8%
17
   3.5%
40
   4.1%
India
14
   2.9%
13
   2.7%
27
   2.8%
Italy
3
   0.6%
10
   2.1%
13
   1.3%
Japan
97
  20.0%
75
  15.6%
172
  17.8%
South Korea
43
   8.9%
48
  10.0%
91
   9.4%
Norway
13
   2.7%
16
   3.3%
29
   3.0%
Romania
29
   6.0%
30
   6.2%
59
   6.1%
Russia
9
   1.9%
13
   2.7%
22
   2.3%
Spain
9
   1.9%
13
   2.7%
22
   2.3%
Netherlands
41
   8.5%
38
   7.9%
79
   8.2%
Turkey
38
   7.9%
39
   8.1%
77
   8.0%
United States
11
   2.3%
17
   3.5%
28
   2.9%
United Arab Emirates
6
   1.2%
3
   0.6%
9
   0.9%
1.Primary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Narrow Band Imaging White Light
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 484 481
Measure Type: Count of Participants
Unit of Measure: Participants
104
  21.5%
109
  22.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection
Hide Description [Not Specified]
Time Frame 3 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description:

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Overall Number of Participants Analyzed 484 481
Measure Type: Count of Participants
Unit of Measure: Participants
59
  12.2%
61
  12.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.742
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description:

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Overall Number of Participants Analyzed 482 478
Measure Type: Count of Participants
Unit of Measure: Participants
None
415
  86.1%
429
  89.7%
I
28
   5.8%
19
   4.0%
II
23
   4.8%
21
   4.4%
IIIA
11
   2.3%
4
   0.8%
IIIB
3
   0.6%
5
   1.0%
IVA
0
   0.0%
0
   0.0%
IVB
0
   0.0%
0
   0.0%
V
2
   0.4%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments [Not Specified]
Method Fisher Exact
Comments The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.
4.Secondary Outcome
Title Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported
Arm/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description:

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Overall Number of Participants Analyzed 484 481
Measure Type: Count of Participants
Unit of Measure: Participants
Bleeding Number Analyzed 431 participants 414 participants
36
   8.4%
27
   6.5%
Fever Number Analyzed 422 participants 407 participants
9
   2.1%
7
   1.7%
UTI Number Analyzed 422 participants 404 participants
8
   1.9%
10
   2.5%
Bladder cramps Number Analyzed 423 participants 407 participants
19
   4.5%
10
   2.5%
DVT Number Analyzed 421 participants 404 participants
0
   0.0%
0
   0.0%
CVA/TIA Number Analyzed 420 participants 404 participants
2
   0.5%
0
   0.0%
Lung embolism Number Analyzed 421 participants 404 participants
0
   0.0%
0
   0.0%
Sepsis Number Analyzed 421 participants 404 participants
2
   0.5%
0
   0.0%
Acute Abdomen Number Analyzed 421 participants 403 participants
1
   0.2%
1
   0.2%
Other perioperative complication Number Analyzed 421 participants 406 participants
9
   2.1%
13
   3.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison of the numbers in 'Bleeding' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison of the numbers in 'Fever' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.666
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'UTI' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'Bladder cramps' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'DVT' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Other Statistical Analysis Non of the participants/patients had DVT. Therefore, the p-value is not available
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'CVA/TIA' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'Lung embolism' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Other Statistical Analysis Non of the participants/patients had a lung embolism. Therefore, no p-value was available
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'Sepsis' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'Acute Abdomen' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments Comparison in the number of 'Other perioperative complication' between NBI and WL
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Recurrence Rate Related to Additional Treatment Following TURB.
Hide Description [Not Specified]
Time Frame Until 135 days
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description:

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

Overall Number of Participants Analyzed 61 70
Measure Type: Number
Unit of Measure: participants
27 27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Narrow Band Imaging, White Light Trans Urethral Resection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Only Serious Adverse Events were monitored
 
Arm/Group Title Narrow Band Imaging White Light Trans Urethral Resection
Hide Arm/Group Description

Narrow Band Imaging (NBI)

Narrow Band Imaging: Narrow Band Imaging

White Light Trans Urethral Resection

White Light: White Light Cystoscopy

All-Cause Mortality
Narrow Band Imaging White Light Trans Urethral Resection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Narrow Band Imaging White Light Trans Urethral Resection
Affected / at Risk (%) Affected / at Risk (%)
Total   25/484 (5.17%)   27/481 (5.61%) 
Cardiac disorders     
patient died of cardiac arrest   1/484 (0.21%)  1/481 (0.21%) 
patient died of heart attack   1/484 (0.21%)  0/481 (0.00%) 
patient died of asystolia   1/484 (0.21%)  0/481 (0.00%) 
Gastrointestinal disorders     
rectorrhagia   0/484 (0.00%)  1/481 (0.21%) 
patient died of intestinal obstruction   1/484 (0.21%)  1/481 (0.21%) 
herniainguinalis   0/484 (0.00%)  1/481 (0.21%) 
patient died of pancreas cancer   1/484 (0.21%)  0/481 (0.00%) 
General disorders     
patient died of unknown cause   2/484 (0.41%)  2/481 (0.42%) 
euthanasia   0/484 (0.00%)  1/481 (0.21%) 
Hepatobiliary disorders     
galbladder carcinoma   0/484 (0.00%)  1/481 (0.21%) 
patient died of biliary tract cancer   1/484 (0.21%)  0/481 (0.00%) 
Infections and infestations     
urinary tract infection   1/484 (0.21%)  1/481 (0.21%) 
campylobacter colitis   0/484 (0.00%)  1/481 (0.21%) 
acute prostatitis   0/484 (0.00%)  1/481 (0.21%) 
infection of unknown origin   0/484 (0.00%)  1/481 (0.21%) 
patient died of septicaemia   1/484 (0.21%)  0/481 (0.00%) 
Injury, poisoning and procedural complications     
patient died by car accident   0/484 (0.00%)  1/481 (0.21%) 
obturator kick   1/484 (0.21%)  0/481 (0.00%) 
urethral injury occurred at time of TUR   1/484 (0.21%)  0/481 (0.00%) 
Musculoskeletal and connective tissue disorders     
hip's fracture   0/484 (0.00%)  1/481 (0.21%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
patient died of another neoplasm   1/484 (0.21%)  0/481 (0.00%) 
patient died of cancer   1/484 (0.21%)  0/481 (0.00%) 
Renal and urinary disorders     
radical cystectomy   1/484 (0.21%)  0/481 (0.00%) 
hydronephrosis   1/484 (0.21%)  0/481 (0.00%) 
transurethral urethrotomy   1/484 (0.21%)  0/481 (0.00%) 
patient died of bladder cancer   2/484 (0.41%)  5/481 (1.04%) 
patient died by renal insuffiency and prostate cancer   1/484 (0.21%)  0/481 (0.00%) 
transurethral resection prostate   0/484 (0.00%)  1/481 (0.21%) 
transurethral urinary resection   0/484 (0.00%)  1/481 (0.21%) 
patient died of kidney failure   0/484 (0.00%)  1/481 (0.21%) 
hematuria   0/484 (0.00%)  1/481 (0.21%) 
radical cystectomy + bricker   1/484 (0.21%)  0/481 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
lung adenocarcinoma   0/484 (0.00%)  1/481 (0.21%) 
patient died of chest infection   1/484 (0.21%)  1/481 (0.21%) 
acute exacerbation of COPD   0/484 (0.00%)  1/481 (0.21%) 
patient died of respiratory insuffiency by bilaterial pneumonia   1/484 (0.21%)  0/481 (0.00%) 
Vascular disorders     
cardiogenic embolism   1/484 (0.21%)  0/481 (0.00%) 
cerebrovascular attack   1/484 (0.21%)  0/481 (0.00%) 
pulmonary embolism   0/484 (0.00%)  1/481 (0.21%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Narrow Band Imaging White Light Trans Urethral Resection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
There is a possibility of observer bias favouring NBI as a limitation of this single-blind study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. de la Rosette, chairman CROES
Organization: CROES
Phone: +31 20 5666030
EMail: info@croesoffice.org
Layout table for additonal information
Responsible Party: Clinical Research Office of the Endourological Society
ClinicalTrials.gov Identifier: NCT01180478    
Other Study ID Numbers: 10-004660
First Submitted: August 10, 2010
First Posted: August 12, 2010
Results First Submitted: August 10, 2017
Results First Posted: April 25, 2018
Last Update Posted: April 25, 2018