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:
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-387OCILK, 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.
POLICY
The use of confocal laser endomicroscopy is considered investigational.
IMPORTANT REMINDERS
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.
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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 June 20, 2023 from https://www.gastrojournal.org/article/S0016-5085(11)00084-9/fulltext.
American Society for Gastrointestinal Endoscopy (ASGE). (2016). ASGE Biliary and Pancreatic Endoscopy Guideline. The role of endoscopy in the diagnosis and treatment of cystic pancreatic neoplasms. Retrieved June 8, 2022 from https://www.asge.org/home/resources/guidelines.
American Society for Gastrointestinal Endoscopy (ASGE). (2019). ASGE guideline on screening and surveillance of Barrett’s esophagus. Retrieved May 26, 2021 from https://www.asge.org/docs/default-source/guidelines.
Beji, S., Wrist Lam, G., Østergren, P. B., Toxvaerd, A., Sønksen, J., & Fode, M. (2021). Diagnostic value of probe-based confocal laser endomicroscopy versus conventional endoscopic biopsies of non-muscle invasive bladder tumors: a pilot study. Scandinavian Journal of Urology, 55 (1), 36–40. Abstract retrieved June 7, 2022 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (12:2022). Confocal laser endomicroscopy (2.01.87). Retrieved June 20, 2023 from www.bcbsaoca.com/eps/. (50 articles and/or guidelines reviewed)
Dittberner, A., Ziadat, R., Hoffmann, F., Pertzborn, D., Gassler, N., & Guntinas-Lichius, O. (2021). Fluorescein-guided panendoscopy for head and neck cancer using handheld probe-based confocal laser endomicroscopy: A pilot study. Frontiers in Oncology, 11, 671880. (Level 2 evidence)
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)
Han, S., Kahaleh, M., Sharaiha, R. Z., Tarnasky, P. R., Kedia, P., Slivka, A., et al. (2021). Probe-based confocal laser endomicroscopy in the evaluation of dominant strictures in patients with primary sclerosing cholangitis: results of a U.S. multicenter prospective trial. Gastrointestinal Endoscopy, 94 (3), 569–576.e1. [ePub ahead of print] doi.10.1016/j.gie.2021.03.027. Abstract retrieved June 8, 2022 from PubMed database.
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)
Kollar, M., Krajciova, J., Prefertusova, L., Sticova, E., Maluskova, J., Vackova, Z., et al. (2020). Probe-based confocal laser endomicroscopy versus biopsies in the diagnostics of oesophageal and gastric lesions: A prospective, pathologist-blinded study. United European Gastroenterology Journal, 8 (4), 436–443. (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. (Level 5 evidence)
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)
Muthusamy, V R., Wani, S., Gyawali, C P., & Komanduri, S. (2022). AGA clinical practice update on new technology and innovation for surveillance and screening in barrett’s esophagus: expert review. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 20 (12) 2696-2706. (Level 5 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.
Schueler, S. A., Gamble, L. A., Curtin, B. F., Ruff, S. M., Connolly, M., Hannah, et al. (2021). Evaluation of confocal laser endomicroscopy for detection of occult gastric carcinoma in CDH1 variant carriers. Journal of Gastrointestinal Oncology, 12 (2), 216–225. (Level 2 evidence)
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.
U.S. Preventive Services Task Force. (2021, May). Final recommendation statement. Colorectal cancer: screening. Retrieved June 8, 2022 from https://www.uspreventiveservicestaskforce.org/uspstf/recommendation.
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: 8/10/2023
ID_BA
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