Trial Outcomes & Findings for Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon (NCT NCT01572428)
NCT ID: NCT01572428
Last Updated: 2019-08-08
Results Overview
Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
898 participants
Primary outcome timeframe
During the colonoscopy procedure
Results posted on
2019-08-08
Participant Flow
Number of patients enrolled(898) differs from number of patients started(804). This is because 94 patients were enrolled but not randomized for various reasons such as inadequate bowel preparation, research personnel/scope not being available, ineligibility of patient per colonoscopist discretion, patient withdrawing consent prior to randomization.
Participant milestones
| Measure |
Narrow-Band Imaging (NBI)
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
402
|
402
|
|
Overall Study
COMPLETED
|
399
|
401
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Baseline characteristics by cohort
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
Total
n=800 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.08 Years
STANDARD_DEVIATION 8.294 • n=5 Participants
|
61.41 Years
STANDARD_DEVIATION 8.251 • n=7 Participants
|
61.25 Years
STANDARD_DEVIATION 8.269 • n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
183 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
339 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
54 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
399 participants
n=5 Participants
|
401 participants
n=7 Participants
|
800 participants
n=5 Participants
|
|
Tobacco use
Current
|
53 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Tobacco use
Past
|
130 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Tobacco use
Never
|
216 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
ASA risk class
1
|
52 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
ASA risk class
2
|
230 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
456 Participants
n=5 Participants
|
|
ASA risk class
3
|
117 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Indication
Screening
|
212 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
|
Indication
Surveillance
|
149 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Indication
Other
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Time from end of colon prep to procedure start
|
6.12 Hours
STANDARD_DEVIATION 2.41 • n=5 Participants
|
6.10 Hours
STANDARD_DEVIATION 1.99 • n=7 Participants
|
6.11 Hours
STANDARD_DEVIATION 2.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: During the colonoscopy procedureTotal quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Any size
|
204 Serrated Lesions
|
158 Serrated Lesions
|
|
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Greater than 5mm in size
|
95 Serrated Lesions
|
59 Serrated Lesions
|
|
Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Greater than or equal to 10mm
|
39 Serrated Lesions
|
20 Serrated Lesions
|
PRIMARY outcome
Timeframe: During the colonoscopy procedureAverage number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Any size
|
0.51 Number of serrated lesions
Standard Deviation 1.18
|
0.39 Number of serrated lesions
Standard Deviation 0.76
|
|
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Greater than 5mm in size
|
0.24 Number of serrated lesions
Standard Deviation 0.70
|
0.15 Number of serrated lesions
Standard Deviation 0.45
|
|
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient
Greater than or equal to 10mm
|
0.10 Number of serrated lesions
Standard Deviation 0.42
|
0.05 Number of serrated lesions
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: During the colonoscopy procedurePatient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Any size
|
105 Participants
|
107 Participants
|
|
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Greater than 5mm in size
|
60 Participants
|
45 Participants
|
|
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Greater than or equal to 10mm
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: During the colonoscopy procedureTotal quantity of adenomas found during colonoscopy procedure.
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Total Number of Conventional Adenomas in Entire Colon
All Sizes
|
438 Conventional Adenomas
|
434 Conventional Adenomas
|
|
Total Number of Conventional Adenomas in Entire Colon
Greater than 5mm in size
|
110 Conventional Adenomas
|
90 Conventional Adenomas
|
|
Total Number of Conventional Adenomas in Entire Colon
Greater than or equal to 10mm
|
29 Conventional Adenomas
|
22 Conventional Adenomas
|
SECONDARY outcome
Timeframe: During the colonoscopy procedureAverage number of adenomas (located anywhere throughout the colon) found per patient.
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Number of Conventional Adenomas Per Patient in Entire Colon
All Sizes
|
1.1 Adenomas per patient
Standard Deviation 1.61
|
1.08 Adenomas per patient
Standard Deviation 1.72
|
|
Number of Conventional Adenomas Per Patient in Entire Colon
Greater than 5mm in size
|
0.28 Adenomas per patient
Standard Deviation 0.62
|
0.22 Adenomas per patient
Standard Deviation 0.67
|
|
Number of Conventional Adenomas Per Patient in Entire Colon
Greater than or equal to 10mm
|
0.07 Adenomas per patient
Standard Deviation 0.30
|
0.05 Adenomas per patient
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: During the colonoscopy procedurePatient had to have at least 1 polyp that was an adenoma.
Outcome measures
| Measure |
Narrow-Band Imaging (NBI)
n=399 Participants
Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)
Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
|
Standard White Light
n=401 Participants
Inspection with Standard White Light versus Narrow-Band Imaging(NBI)
Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
|
|---|---|---|
|
Patients With 1 or More Conventional Adenomas
Greater than or equal to 10mm
|
25 Participants
|
18 Participants
|
|
Patients With 1 or More Conventional Adenomas
Any size
|
202 Participants
|
189 Participants
|
|
Patients With 1 or More Conventional Adenomas
Greater than 5mm in size
|
84 Participants
|
61 Participants
|
Adverse Events
Narrow-Band Imaging (NBI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard White Light
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place