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Completed

NCT Number: NCT01310699

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Polyps Colorectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Palo Alto, Palo Alto, California, United States

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About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olympus Colonoscope CFHQ190AL

Device

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Percentage of Missed Lesions on Index Colonoscopy.

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

    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.

  2. Percentage of Nonpolypoid (Flat) Missed Lesions

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

    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.

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • Kansas City Veteran Affairs Medical Center

Registry information

Official study title

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

Acronym: NBI

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2011
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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