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Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasms, Colonic Polyps, Colorectal Cancer

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Trial Information

Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study


Interval colorectal cancers diagnosed within a three year period following a clearing
colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these
cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy.
Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or
detection rates using narrow band imaging as compared to colonoscopy using white light.
However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis
and should be furthered studied, especially considering that they are thought to be a strong
contributor to a false negative colonoscopy.


Inclusion Criteria:



- Adult patients referred for routine colonoscopy are eligible

Exclusion Criteria:

- Known Inflammatory bowel disease

- Referred for endoscopic evaluation and removal of colorectal lesion

- Personal or family history of polyposis or non-polyposis syndrome

- Presentation for emergency endoscopy

- Inability to remove polyp due to coagulopathy or thrombocytopenia

- Inability to provide informed consent

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:

Nonpolypoid (flat and depressed) colorectal neoplasm detection.

Outcome Description:

Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Tonya Kaltenbach, MD MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Veterans Affairs Palo Alto

Authority:

United States: Federal Government

Study ID:

FIND FLAT PA19624

NCT ID:

NCT01310699

Start Date:

January 2013

Completion Date:

December 2013

Related Keywords:

  • Colorectal Neoplasms
  • Colonic Polyps
  • Colorectal Cancer
  • Colonoscopy
  • Diagnostic imaging
  • Colorectal Neoplasm
  • Tandem Colonoscopy
  • Flat Polyp
  • Nonpolypoid
  • Flat and Depressed Lesions
  • Primary Prevention
  • Endoscopy
  • Neoplasms
  • Colonic Polyps
  • Colorectal Neoplasms
  • Polyps

Name

Location
Veterans Affairs Palo Alto Palo Alto, California  94304
Veterans Affairs Kansas City Kansas City, Missouri  64128