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

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ClinicalTrials.gov Identifier: NCT01310699

Recruitment Status : Completed

First Posted : March 8, 2011

Results First Posted : April 6, 2017

Last Update Posted : December 6, 2017

Sponsor:

Collaborator:

Kansas City Veteran Affairs Medical Center

Information provided by (Responsible Party):

Roy Soetikno, VA Palo Alto Health Care System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Neoplasms Colonic Polyps Colorectal Cancer	Device: Olympus Colonoscope CFHQ190AL	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	281 participants
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
Study Start Date :	January 2013
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy Colorectal Cancer Diagnostic Imaging

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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.

Eligibility Criteria

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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:

Click here for more information about non-polypoid (flat and depressed) colorectal polyps: This link exits the ClinicalTrials.gov site

Publications:

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.

Kaltenbach 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.

Kaltenbach 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. Review.

Rex DK, Bond JH, Feld AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol. 2001 Apr;96(4):952-7. Review.

Rex 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. Epub 2007 Apr 20.

van 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. Review.


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 Posted:	March 8, 2011 Key Record Dates
Results First Posted:	April 6, 2017
Last Update Posted:	December 6, 2017
Last Verified:	October 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

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