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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • VA Palo Alto Health Care System
  • Collaborator
    • Kansas City Veteran Affairs Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roy Soetikno, Co-Principal Investigator – VA Palo Alto Health Care System
  • Overall Official(s)
    • Tonya Kaltenbach, MD MS, Principal Investigator, San Francisco Veterans Affairs Medical Center

References

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.

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.

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.

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.

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