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

Colorectal Cancer Clinical Trial

— NBI  

Official title:

Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310699
• Other study ID #: FIND FLAT PA19624
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: October 31, 2017
• Start date: January 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyps
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Intervention

Device:
• Olympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.

Locations

Country	Name	City	State
United States	Veterans Affairs Kansas City	Kansas City	Missouri
United States	Veterans Affairs Palo Alto	Palo Alto	California
United States	Veterans Affairs San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Kansas City Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View 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. Epub 2007 Apr 20. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Missed Lesions on Index Colonoscopy.	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.	One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Secondary	Percentage of Nonpolypoid (Flat) Missed Lesions	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.	One week (time of procedure plus time for pathology of polyp to be analyzed by histology)

External Links

•   Click here for more information about non-polypoid (flat and depressed) colorectal polyps: