BlueCross BlueShield of Tennessee Medical Policy Manual

Confocal Laser Endomicroscopy

DESCRIPTION

Confocal laser endomicroscopy (CLE), also known as confocal fluorescent endomicroscopy and optical endomicroscopy, allows in vivo microscopic imaging of the mucosal epithelium during endoscopy. CLE is proposed for a variety of purposes, especially as a real-time alternative to biopsy/polypectomy and histopathologic analysis during colonoscopy and for targeting areas to undergo biopsy in individuals with inflammatory bowel disease or Barrett esophagus. CLE focuses laser light on the mucosal lining, magnifying the tissue and cellular structures approximately 1000 times. CLE can image structures to a depth of approximately 55 to 250 micrometers. CLE illuminates the target area with a blue laser light (488 nanometers [nm] wavelength) following the topical application or intravenous administration of a fluorescent agent. Endoscopic CLE is performed using a confocal laser imaging microscope integrated into the tip of a standard wide-field, high-definition white light endoscope. Images are acquired by placing the imaging aperture directly in contact with the esophageal mucosa; the images are then displayed on a screen similar to standard endoscopy. The working channel of the endoscope remains free for the operator to take targeted biopsies or perform other functions. Individuals undergo conscious sedation for the procedure and receive IV fluorescein to enhance the CLE images.

To date, two types of CLE systems have been cleared for marketing by the U.S. Food and Drug Administration: 

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

This policy does not address narrow band imaging (NBI), autofluorescence imaging (AFI) or ‘white-light’ technology.

Currently the evidence to support this technology is insufficient to determine the effects of the technology on health outcomes.

SOURCES 

American Gastroenterological Association (AGA). (2011). American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Retrieved February 19, 2013 from https://www.gastro.org/guidelines/esophageal-and-gastric-disorders.

BlueCross BlueShield Association. Evidence Positioning System. (11:2017). Confocal laser endomicroscopy (2.01.87). Retrieved October 1, 2018 from https://www.evidencepositioningsystem.com/. (36 articles and/or guidelines reviewed)

Fugazza, A., Gaiani, F., Carra, M., Brunetti, F., Lévy, M., Sobhani, I., et al. (2016) Confocal laser endomicroscopy in gastrointestinal and pancreatobiliary diseases: a systematic review and meta-analysis. BioMed Research International, Vol. 2016, Article ID 4638683. (Level 2 evidence)

He, X., Liu, D., & Sun, L. (2016). Diagnostic performance of confocal laser endomicroscopy for optical diagnosis of gastric intestinal metaplasia: a meta-analysis. BMC Gastroenterology,16,109. (Level 2 evidence)

Li, H., Hou, X., Lin, R., Fan, M., Pang, S., Jiang, L., et al. (2019). Advanced endoscopic methods in gastrointestinal diseases: a systematic review. Quantitative Imaging in Medicine and Surgery, 9 (5), 905-920. Abstract retrieved September 10, 2019 from PubMed database.

Lord, R., Burr, N., Mohammed, N., & Subramanian, V. (2018). Colonic lesion characterization in inflammatory bowel disease: a systematic review and meta-analysis. World Journal of Gastroenterology, 24 (10), 1167-1180. (Level 1 evidence)

Qian, W., Bai, T., Wang, H., Zhang, L., Song, J., & Hou, X. (2016). Meta-analysis of confocal laser endomicroscopy for the diagnosis of gastric neoplasia and adenocarcinoma. Journal of Digestive Diseases, 17 (6), 366-376, Abstract retrieved November 15, 2016 from PubMed database.

Sharma, P., Brill, J., Canto, M., DeMarco, D., Fennerty, B.,Gupta, N., et al. (2015). White paper AGA: advanced imaging in Barrett’s esophagus. Clinical Gastroenterology and Hepatology, 13 (3), 2209-2218. Retrieved October 1, 2018 from https://www.cghjournal.org.

U. S. Food and Drug Administration. (2004, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K042741 (EC-3870C1LK). Retrieved February 19, 2013 from http://www.accessdata.fda.gov

U. S. Food and Drug Administration. (2012, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K122042 (Cellvizio®). Retrieved February 19, 2013 from http://www.accessdata.fda.gov.

Xiong, Y.Q., Ma, S.J., Hu, H.Y., Ge, J., Zhou, L.Z., Huo, S.T., et al. (2018). Comparison of narrow-band imaging and confocal laser endomicroscopy for the detection of neoplasia in Barrett’s esophagus: a meta-analysis. Clinics and Research in Hepatology and Gastroenterology, 42 (1), 31-39. Abstract retrieved September 10, 2019 from PubMed database.

Xiong, Y.Q., Ma, S.J., Zhou, J.H., Zhong, X.S., & Chen, Q. (2016). A meta-analysis of confocal laser endomicroscopy for the detection of neoplasia in patients with Barrett’s esophagus. Journal of Gastroenterology and Hepatology, 31 (6), 1102-1110. Abstract retrieved October 1, 2018 from PubMed database.

ORIGINAL EFFECTIVE DATE:  8/10/2013

MOST RECENT REVIEW DATE:  10/10/2019    

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.