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

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:

MedlinePlus related topics: Cancer Colonic Polyps Colonoscopy Colorectal Cancer Depression

U.S. FDA Resources

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

Primary Outcome Measures:

Nonpolypoid (flat and depressed) colorectal neoplasm detection. [ Time Frame: 9 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: 9 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: 9 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: 9 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.

Estimated Enrollment:	600
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High Definition NBI Colonoscopy	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	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

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
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:

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.

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. 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. 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. Review. No abstract available.

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:	January 6, 2013
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 May 22, 2013