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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

NCT ID: NCT01310699

Last Updated: 2017-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Neoplasms Colonic Polyps Colorectal Cancer

Keywords

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Colonoscopy Diagnostic imaging Colorectal Neoplasm Tandem Colonoscopy Flat Polyp Nonpolypoid Flat and Depressed Lesions Primary Prevention Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Olympus Colonoscope CFHQ190AL

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

Olympus Colonoscope CFHQ190AL

Intervention Type DEVICE

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

Interventions

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Olympus Colonoscope CFHQ190AL

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kansas City Veteran Affairs Medical Center

FED

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Roy Soetikno

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tonya Kaltenbach, MD MS

Role: PRINCIPAL_INVESTIGATOR

San Francisco Veterans Affairs Medical Center

Locations

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Veterans Affairs Palo Alto

Palo Alto, California, United States

Site Status

Veterans Affairs San Francisco

San Francisco, California, United States

Site Status

Veterans Affairs Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18319413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18523025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20656245 (View on PubMed)

Rex 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.

Reference Type BACKGROUND
PMID: 11316211 (View on PubMed)

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. doi: 10.1053/j.gastro.2007.04.029. Epub 2007 Apr 20.

Reference Type BACKGROUND
PMID: 17631129 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 19111693 (View on PubMed)

Other Identifiers

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FIND FLAT PA19624

Identifier Type: -

Identifier Source: org_study_id