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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310699
First Posted: March 8, 2011
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
  Purpose
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.

Condition Intervention
Colorectal Neoplasms Colonic Polyps Colorectal Cancer Device: Olympus Colonoscope CFHQ190AL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study

Resource links provided by NLM:


Further study details as provided by Roy Soetikno, VA Palo Alto Health Care System:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 281
Study Start Date: January 2013
Estimated Study Completion Date: June 2017
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Definition NBI Colonoscopy
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.
Device: Olympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.
Placebo Comparator: High Definition White Light Colonoscopy
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.
Device: Olympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310699


Locations
United States, California
Veterans Affairs Palo Alto
Palo Alto, California, United States, 94304
Veterans Affairs San Francisco
San Francisco, California, United States, 94121
United States, Missouri
Veterans Affairs Kansas City
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
VA Palo Alto Health Care System
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Tonya Kaltenbach, MD MS San Francisco Veterans Affairs Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Roy Soetikno, Co-Principal Investigator, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01310699     History of Changes
Other Study ID Numbers: FIND FLAT PA19624
First Submitted: March 7, 2011
First Posted: March 8, 2011
Results First Submitted: February 21, 2017
Results First Posted: April 6, 2017
Last Update Posted: June 22, 2017
Last Verified: May 2017

Keywords provided by Roy Soetikno, VA Palo Alto Health Care System:
Colonoscopy
Diagnostic imaging
Colorectal Neoplasm
Tandem Colonoscopy
Flat Polyp
Nonpolypoid
Flat and Depressed Lesions
Primary Prevention
Endoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Polyps
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Intestinal Polyps