Narrow Band Imaging Colon Polyp Study - Full Text View

Sponsors and Collaborators:	Kansas City Veteran Affairs Medical Center American Society for Gastrointestinal Endoscopy Midwest Biomedical Research Foundation
Information provided by:	Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00614770

Purpose

In this study the investigators hypothesize that narrow band imaging (NBI) will have a high accuracy in predicting polyp histology in real time during a colonoscopy by visualization of the surface mucosal and vascular patterns.

Specific Aim 1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy.

Specific Aim 2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns

Condition	Intervention
Adenomatous Polyp Neoplastic Polyp	Procedure: standard of care colonoscopy Procedure: colonoscopy

MedlinePlus related topics: Colonoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment

Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:

The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcome will include the inter-observer variability in reading of mucosal and vascular patterns (by kappa statistics). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	630
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Standard White Light Colonoscopy	Procedure: standard of care colonoscopy Standard White Light Colonoscopy one exam per patient
2: Experimental High Definition White Light Colonoscopy	Procedure: standard of care colonoscopy High Definition White Light Colonoscopy one exam per patient
3: Experimental Narrow Band Imaging Colonoscopy	Procedure: colonoscopy Narrow Band Imaging Colonoscopy one exam per patient

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Referral for screening or surveillance colonoscopy
The ability to produce informed consent

Exclusion Criteria:

Prior surgical resection of any portion of colon
Prior history of colon cancer
History of inflammatory bowel disease
Use of anti-platelet agents or anticoagulants that preclude removal of polyps during the procedure
Poor general condition or any other reason to avoid prolonged procedure time
History of polyposis syndrome or hereditary nonpolyposis colorectal cancer (HNPCC)
Inability to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614770

Contacts

Contact: Vikas Singh

816 861 4700 ext 56428

vikas.singh@va.gov

Locations

United States, Missouri
Kansas City VA Medical Center	Recruiting
Kansas City, Missouri, United States, 64128

Sponsors and Collaborators

Kansas City Veteran Affairs Medical Center

American Society for Gastrointestinal Endoscopy

Midwest Biomedical Research Foundation

Investigators

Principal Investigator:

Amit Rastogi, MD

Kansas City VA Medical Center

More Information

No publications provided

Responsible Party:	Kansas City VA Medical Center ( Amit Rastogi, MD )
Study ID Numbers:	AR0003, AR0003
Study First Received:	January 31, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00614770
Health Authority:	United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:

colonoscopy

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Colonic Polyps
Polyps

Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2009