Clinical trial NCT01310699: Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
Official title: Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyps
Colorectal Cancer
Keywords: Colonoscopy
Diagnostic imaging
Colorectal Neoplasm
Tandem Colonoscopy
Flat Polyp
Nonpolypoid
Flat and Depressed Lesions
Primary Prevention
Endoscopy
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Kansas City Veteran Affairs Medical Center
First posted: 2011-03-08
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
timeFrame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Secondary outcomes:
measure: Percentage of Missed Lesions on Index Colonoscopy.
timeFrame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
measure: Percentage of Nonpolypoid (Flat) Missed Lesions
timeFrame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto
state: California
city: San Francisco
country: United States
facility: Veterans Affairs San Francisco
state: California
city: Kansas City
country: United States
facility: Veterans Affairs Kansas City
state: Missouri
Study officials:
affiliation: San Francisco Veterans Affairs Medical Center
name: Tonya Kaltenbach, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.