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:
Cellvizio® (Mauna Kea Technologies; Paris, France): This is a confocal microscopy with a fiber optic probe (i.e., a probe-based CLE system that consists of a laser scanning unit, proprietary software, miniaturized fiber optic probes and a flat-panel display)
EC-3S7OCILK, Confocal Video Colonoscope (Pentax Medical Company; Montvale, NJ): This is an endoscopy-based CLE system that is used with a Pentax video processor and with the Pentax confocal laser system.
The use of confocal laser endomicroscopy is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
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.
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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