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 System281 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

281

Conditions

Colorectal Neoplasms Colonic Polyps Colorectal Cancer

Interventions

Olympus Colonoscope CFHQ190ALDEVICE

Technically improved colonoscope with close focus high definition narrow band imaging.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Veterans Affairs Palo Alto

Palo Alto, California, United States

Veterans Affairs San Francisco

San Francisco, California, United States

Veterans Affairs Kansas City

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm

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

Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)

Secondary Outcomes

Percentage of Missed Lesions on Index Colonoscopy.

Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.

Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)

Percentage of Nonpolypoid (Flat) Missed Lesions

Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.

Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)

Data from ClinicalTrials.gov

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