Clinical Evaluation of Narrow Band Imaging Colonoscope

NCT ID: NCT00628147

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-03-31

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.

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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Narrow band imaging colonoscope

narrow band imaging colonoscope

Group Type: EXPERIMENTAL

Narrow band imaging colonoscope

Intervention Type: DEVICE

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.

White Light

Conventional White Light Examination

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

CF-H180AL; CF-Q180AL; Evis Exera II CV-180

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: lead

Responsible Party

Roy Soetikno

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roy Soetikno, MD, MS

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

VAPaloAltoHCS

Palo Alto, California, United States

Countries

United States

References

Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.

Reference Type: DERIVED

PMID: 18523025 (View on PubMed)

Other Identifiers

SOE0011

Identifier Type: -

Identifier Source: org_study_id