In Vivo Analysis of Colorectal Polyps
DESCRIPTION
During a screening colonoscopy or sigmoidoscopy for colorectal cancer, the physician must often decide which polyp should be removed for histologic diagnosis. While hyperplastic polyps are considered benign without malignant potential, adenomatous polyps are thought to represent one of the earliest stages in the progression to a malignancy. Identification of these premalignant lesions is considered one of the cornerstones of colorectal cancer prevention.
Recently a spectrophotometry technique has been developed as an adjunct to colonoscopy that is intended to distinguish between normal and precancerous tissue. This system is based on the observation that benign and malignant tissue emits different patterns and wavelengths of fluorescence after exposure to a laser light. One such device was approved by the U.S. Food and Drug Administration (FDA) in 2000, the Optical Biopsy System (SpectraScience, Minneapolis MN). This system consists of an optical fiber emitting a laser that is directed against 3 different regions of the same polyp. The subsequent fluorescent signal is collected, measured, and analyzed by a proprietary system software, and classifies a polyp as "suspicious" (i.e., adenomatous) or "not suspicious" (i.e., hyperplastic). The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove and is indicated for use as an adjunct to lower gastrointestinal endoscopy.
Narrow band imaging (NBI) is another new technique that allows visualization of the mucosal surface and capillary vessels and thus may assist in the differentiation of abnormal from normal mucosa during colonoscopy. NBI has limited penetration into the mucosal surface and has enhanced visualization of capillary vessels and their fine structure on the surface layer of colonic tissue.
NBI received FDA clearance through the 510K process in 2005. This clearance (K051645) added NBI with the EVIS EXERA 160A System (Olympus Medical Systems Corp) to existing endoscopic equipment. FDA indications are for endoscopic diagnosis, treatment, and video observation.
POLICY
In vivo analysis of colorectal polyps for the identification of pre-cancerous tissue is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
In the absence of any well-designed randomized controlled trials, no conclusions can be drawn about whether in vivo analysis of colorectal polyps has an effect on health outcomes. Randomized trials in which participants receive both screening tests, and histological confirmation of disease is matched to the screening results for each polyp are needed to evaluate this technology.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2009). In vivo analysis of colorectal polyps - Archived (2.01.51). Retrieved May 18, 2011 from BlueWeb. (24 articles and/or guidelines reviewed)
Chiu, H., Chang, C., Chen, C., Lee, Y., Wu, M., Lin, J., et al. (2007) A prospective comparative study of narrow-band imaging, chromoendoscopy, and conventional colonoscopy in the diagnosis of colorectal neoplasia. Gut. 56 (3), 373-379. (Level 3 Evidence - Independent)
Emura, F., Saito, Y., & Ikematsu, H. (2008) Narrow band imaging optical colonoscopy: Advantages and limitations. World Journal of Gastroenterology, 14 (31), 4867- 4872.
National Guideline Clearinghouse. (2006, May). Guidelines for colonoscopy surveillance after polypectomy: A consensus update by the US Multi-Society Task force on Colorectal Cancer and the American Cancer Society. Retrieved April 19, 2011 from http://www.guideline.gov/summary/summary.aspx?doc_id=11878&nbr=006080&string=na.
U. S. Food and Drug Administration. (2000. November). Center for Devices and Radiological Health. Premarket Notification Database. P990050b. Retrieved April 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/P990050b.pdf.
U. S. Food and Drug Administration. (2005. October). Center for Devices and Radiological Health. 510k Premarket Notification Database. K051645. Retrieved April 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051645.pdf.
MOST RECENT REVIEW DATE: 6/9/2011
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