Clinical Evaluation of Narrow Band Imaging Colonoscope

• Sponsor: VA Palo Alto Health Care System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00628147
• Collaborator: (none)
• Enrollment: 284
• Location: 1
• Arms: 2
• Duration (Months): 13.9
• Patients Per Site Per Month: 20.4

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Device: Narrow band imaging colonoscope	Phase 4

Detailed Description

This is a clinical study to evaluate whether the use of a new type of colonoscope may improve the detection of colon polyps. Though colonoscopy is currently the best test for colon cancer screening, it remains imperfect. Research has found that about 25% of polyps may actually be missed during colonoscopy using standard full spectrum white light imaging. Advances in colonoscopic technology hold the potential to decrease the miss rate of colorectal neoplasms. A new colonoscope uses narrow band imaging, whereby the colon is illuminated using only a subset of the white light spectrum, 415nanometers (blue) and 540 nanometers (green) rather than the standard full spectrum white light (red, green and blue). Initial studies by other groups suggest that these narrow band images highlight small blood vessels of colon polyps. As such, we hypothesized that the use of NBI would improve the identification of neoplasms through the color differentiation of precancerous or cancerous polyp (appearing brown) from normal colon mucosal lining (appearing green), and potentially lead to a reduction in polyp miss rate. We aimed to study the polyp miss rate, and compare narrow band imaging to white light examination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Narrow band imaging colonoscope narrow band imaging colonoscope	Device: Narrow band imaging colonoscope; Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.; Other Names: CF-H180AL CF-Q180AL Evis Exera II CV-180
No Intervention: White Light Conventional White Light Examination

Outcome Measures

Primary Outcome Measures

1. Neoplasm Miss Rate [same day]

Secondary Outcome Measures

1. Neoplasm Detection Rates [same day]

2. Completion of Examinations [same day]

3. Procedure Complications [procedure and post-procedure complications within 30 days after colonoscopy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• referred for elective outpatient colonoscopy

Exclusion Criteria:

• known inflammatory bowel disease

• personal or family history of polyposis syndrome

• referral for resection of a known lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VAPaloAltoHCS	Palo Alto	California	United States	94304

Sponsors and Collaborators

• VA Palo Alto Health Care System

Investigators

• Principal Investigator: Roy Soetikno, MD, MS, VA Palo Alto Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roy Soetikno, Clinical Professor, VA Palo Alto Health Care System
• ClinicalTrials.gov Identifier: NCT00628147
• Other Study ID Numbers: SOE0011
• First Posted: Mar 4, 2008
• Last Update Posted: Mar 8, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Roy Soetikno, Clinical Professor, VA Palo Alto Health Care System: colonic neoplasms; colonoscopy; narrow band imaging; diagnostic techniques
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination
Period Title: Overall Study
STARTED	142	142
COMPLETED	135	141
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light	Total
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination	Total of all reporting groups
Overall Participants	142	142	284
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (10)	64 (10)	64 (10)
Gender (Count of Participants)
Female	5 3.5%	4 2.8%	9 3.2%
Male	137 96.5%	138 97.2%	275 96.8%

Outcome Measures

1. Primary Outcome

Title	Neoplasm Miss Rate
Time Frame	same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination
Measure Participants	135	141
Number (95% Confidence Interval) [Miss rate percentage]	12.6	12.1

2. Secondary Outcome

Title	Neoplasm Detection Rates
Time Frame	same day

Outcome Measure Data

Analysis Population Description

We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination
Measure Participants	135	141
Overall	69 48.6%	66 46.5%
Screening	29 20.4%	31 21.8%
Non-Screening	40 28.2%	35 24.6%

3. Secondary Outcome

Title	Completion of Examinations
Time Frame	same day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination
Measure Participants	135	141
Count of Participants [Participants]	135 95.1%	141 99.3%

4. Secondary Outcome

Title	Procedure Complications
Time Frame	procedure and post-procedure complications within 30 days after colonoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow Band Imaging Colonoscope	White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	Conventional White Light Examination
Measure Participants	135	141
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Narrow Band Imaging Colonoscope		White Light
Arm/Group Description	Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.		Conventional White Light Examination
All Cause Mortality
	Narrow Band Imaging Colonoscope		White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Narrow Band Imaging Colonoscope		White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/142 (0%)		0/142 (0%)
Other (Not Including Serious) Adverse Events
	Narrow Band Imaging Colonoscope		White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/142 (0%)		0/142 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.