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


Phase 4
18 Years
N/A
Not Enrolling
Both
Colonic Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

neoplasm miss rate

Outcome Time Frame:

same day

Safety Issue:

No

Principal Investigator

Roy Soetikno, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

VA Palo Alto Health Care System

Authority:

United States: Federal Government

Study ID:

SOE0011

NCT ID:

NCT00628147

Start Date:

January 2006

Completion Date:

March 2007

Related Keywords:

  • Colonic Neoplasms
  • colonic neoplasms
  • colonoscopy
  • narrow band imaging
  • diagnostic techniques
  • Neoplasms
  • Colonic Neoplasms

Name

Location

VAPaloAltoHCS Palo Alto, California  94304