Clinical Evaluation of Narrow Band Imaging Colonoscope

Colonic Neoplasms Clinical Trial

Official title:

Tandem Colonoscopy Study of Narrow Band Imaging Versus White Light Examination to Compare Neoplasia Miss Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628147
• Other study ID #: SOE0011
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2008
• Last updated: March 3, 2008
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2008
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	VAPaloAltoHCS	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neoplasm miss rate		same day	No
Secondary	neoplasm detection rates		same day	No
Secondary	completion of examinations		same day	No
Secondary	procedure complications		procedure and post-procedure complications within 30 days after colonoscopy	Yes