Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study

VA Palo Alto Health Care System

Status: Completed

Conditions: Colonic Polyps; Colorectal Neoplasms; Colorectal Cancer

Treatments: Device: Olympus Colonoscope CFHQ190AL

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01310699

FIND FLAT PA19624

Details and patient eligibility

About

We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.

Full description

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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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281 participants in 2 patient groups, including a placebo group

High Definition NBI Colonoscopy

Experimental group

Description:

Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Treatment:

Device: Olympus Colonoscope CFHQ190AL

High Definition White Light Colonoscopy

Placebo Comparator group

Description:

Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Treatment:

Device: Olympus Colonoscope CFHQ190AL