Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
NBI
Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study
1 other identifier
interventional
281
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 6, 2017
CompletedDecember 6, 2017
October 1, 2017
3.3 years
March 7, 2011
February 21, 2017
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Secondary Outcomes (2)
Percentage of Missed Lesions on Index Colonoscopy.
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Percentage of Nonpolypoid (Flat) Missed Lesions
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Study Arms (2)
High Definition NBI Colonoscopy
EXPERIMENTALUse 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.
High Definition White Light Colonoscopy
PLACEBO COMPARATORUse 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.
Interventions
Technically improved colonoscope with close focus high definition narrow band imaging.
Eligibility Criteria
You may qualify if:
- Adult patients referred for routine colonoscopy are eligible
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Veterans Affairs Palo Alto
Palo Alto, California, 94304, United States
Veterans Affairs San Francisco
San Francisco, California, 94121, United States
Veterans Affairs Kansas City
Kansas City, Missouri, 64128, United States
Related Publications (6)
Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027.
PMID: 18319413BACKGROUNDKaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.
PMID: 18523025BACKGROUNDKaltenbach T, Soetikno R. Image-enhanced endoscopy is critical in the detection, diagnosis, and treatment of non-polypoid colorectal neoplasms. Gastrointest Endosc Clin N Am. 2010 Jul;20(3):471-85. doi: 10.1016/j.giec.2010.04.001.
PMID: 20656245BACKGROUNDRex DK, Bond JH, Feld AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol. 2001 Apr;96(4):952-7. doi: 10.1111/j.1572-0241.2001.03677.x.
PMID: 11316211BACKGROUNDRex DK, Helbig CC. High yields of small and flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology. 2007 Jul;133(1):42-7. doi: 10.1053/j.gastro.2007.04.029. Epub 2007 Apr 20.
PMID: 17631129BACKGROUNDvan den Broek FJ, Reitsma JB, Curvers WL, Fockens P, Dekker E. Systematic review of narrow-band imaging for the detection and differentiation of neoplastic and nonneoplastic lesions in the colon (with videos). Gastrointest Endosc. 2009 Jan;69(1):124-35. doi: 10.1016/j.gie.2008.09.040. No abstract available.
PMID: 19111693BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tonya Kaltenbach
- Organization
- San Francisco VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Tonya Kaltenbach, MD MS
San Francisco Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
January 1, 2013
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
December 6, 2017
Results First Posted
April 6, 2017
Record last verified: 2017-10