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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by VA Palo Alto Health Care System
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01310699
First received: March 7, 2011
Last updated: June 11, 2014
Last verified: June 2014
  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 Phase
Colorectal Neoplasms
Colonic Polyps
Colorectal Cancer
Device: Technically Improved High Definition NBI Colonoscopy System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Nonpolypoid (flat and depressed) colorectal neoplasm detection. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • Assess the number of missed lesions on index colonoscopy. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Stratify missed and detected lesion by morphology. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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, stratified by lesion shape.

    Compare the number detected lesions using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, stratified by lesion shape.


  • Impact on surveillance interval recommendations. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Compare the accuracy of surveillance colonoscopy interval recommendations based on the index colonoscopy using the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy; incorporating the tandem colonoscopy findings.

  • Optical Diagnosis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Will assess real-time performance of optical diagnosis of colorectal polyps, using pathology as the reference standard.


Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2020 (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.
Device: Technically Improved High Definition NBI Colonoscopy System
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.
Device: Technically Improved High Definition NBI Colonoscopy System
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310699

Contacts
Contact: Tonya Kaltenbach, MD MS 650-493-5000 ext 64800 tonya.kaltenbach@va.gov
Contact: Roy Soetikno, MD MS 650-493-5000 ext 64800 roy.soetikno@va.gov

Locations
United States, California
Veterans Affairs Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Tonya Kaltenbach, MD MS    650-493-5000 ext 64800    tonya.kaltenbach@va.gov   
Contact: Roy Soetikno, MD MS    650-493-5000 ext 64800    roy.soetikno@va.gov   
Principal Investigator: Tonya Kaltenbach, MD MS         
Principal Investigator: Roy Soetikno, MD MS         
Veterans Affairs San Francisco Not yet recruiting
San Francisco, California, United States, 94121
Sub-Investigator: Kenneth McQuaid, MD         
United States, Missouri
Veterans Affairs Kansas City Not yet recruiting
Kansas City, Missouri, United States, 64128
Contact: Amit Rastogi, MD    816-861-4700 ext 56725    amit.rastogi@va.gov   
Principal Investigator: Amit Rastogi, MD         
Sponsors and Collaborators
VA Palo Alto Health Care System
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Tonya Kaltenbach, MD MS Veterans Affairs Palo Alto
Principal Investigator: Roy Soetikno, MD MS Veterans Affairs Palo Alto
  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
Study First Received: March 7, 2011
Last Updated: June 11, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by 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:
Neoplasms
Colonic Polyps
Colorectal Neoplasms
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014