Ablation Treatments for Barrett’s Esophagus
DESCRIPTION
Barrett’s esophagus is a precancerous condition defined by metaplastic changes in which the normal squamous epithelium of the esophagus is replaced by a columnar epithelium containing goblet cells (i.e. intestinal metaplasia or IM). These metaplastic changes are triggered by the inflammation and injury caused by chronic gastroesophageal reflux or chronic esophagitis and are associated with an increased risk of developing adenocarcinoma of the esophagus. Barrett’s esophagus is confirmed by biopsy of the epithelium and microscopic identification of the metaplastic cells.
Radiofrequency ablation (RFA), a treatment for Barrett’s esophagus (BE), uses bipolar electrodes and an ablation catheter or balloon to rapidly deliver radiofrequency energy to the dysplastic tissue. It is repeated until all the identified diseased tissue of the superficial epithelium is ablated or destroyed and removed without damaging the submucosa. The goal of treatment is histological eradication of dysplastic cells and reduction of risk for neoplastic progression or development of adenocarcinoma of the esophagus.
Cryotherapy is another form of ablation being studied as a potential treatment for BE. Cryotherapy uses a low-pressure spray for spraying liquid nitrogen through an upper endoscope it allows for treatment of uneven surfaces of the BE tissue. Disadvantages include the uneven application inherent in spraying the cryogen. Currently this modality is being reviewed in clinical trials. The CryoSpray Ablation™ System (formerly the SprayGenix™ Cryo Ablation System, CSA Medical, Inc.) is an example of the cryotherapy device.
POLICY
Radiofrequency ablation (RFA) for treatment of Barrett’s esophagus with biopsy confirmed dysplasia is considered medically necessary.
Radiofrequency ablation for treatment of Barrett’s esophagus in the absence of dysplasia is considered investigational.
Cryoablation for the treatment of Barrett’s esophagus, with or without dysplasia is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
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ADDITIONAL INFORMATION
Histological grading of Barrett’s biopsy specimens:
Non neoplastic intestinal metaplasia
Indefinite for neoplasia (IND)
Low-grade intraepithelial neoplasia (LGIN)
High-grade intraepithelial neoplasia (HGIN)
The HALO360 received U.S. Food and Drug Administration (FDA) 510(k) clearance for marketing in 2005 and the HALO 90 in 2006. The FDA-labeled indications are for use in coagulation of bleeding and nonbleeding sites in the gastrointestinal tract, and include the treatment of Barrett’s esophagus. The CryoSpray Ablation™ System received FDA 510(k) marketing clearance in December 2007 for use as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
For Radiofrequency Ablation multiple specimen biopsies are to be evaluated by network pathologists to determine the presence or absence of dysplasia in the Barrett’s esophagus before the RFA is done.
Current published data showing the efficacy of cryoablation in Barrett’s esophagus is limited. This modality of ablation remains in clinical trials.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2010). Endoscopic Radiofrequency Ablation or Cryoablation for Barrett’s Esophagus (2.01.80). Retrieved June 9, 2011 from BlueWeb. (22 articles and/ or guidelines reviewed)
Chennat, J., Konda, V., & Waxman, I. (2011). Endotherapy for Barrett’s esophagus: Which, how, when, and who? Gastrointestinal Endoscopy Clinic of North America, 21 (1), 119-133. (Level 5 evidence - Independent)
Dumot, J., Vargo, J., Falk, G., Frey, L., Lopez, R., & Rice, T. (2009). An open-label, prospective trial of cryospray ablation for Barrett’s esophagus high-grade dysplasia and early esophageal cancer in high-risk patients. Gastrointestinal Endoscopy, 70 (4), 635 - 644. (Level 2 Evidence - Independent)
ECRI Institute. Health technology Information Service. Emerging Techology (TARGET) Evidence Report. (2009, December). Endoscopic radiofrequency ablation for Barrett’s esophagus. Retrieved June 9, 2011 from ECRI Institute. (37 articles and/or guidelines reviewed)
Fernando, H., Murthy, S., Hofstetter, W., Shrager, J., Bridges, C., Mitchell, J. et al. (2009). The Society of Thoracic Surgeons practice guideline series: Guidelines for the management of Barrett’s esophagus with high-grade dysplasia. Annals of Thoracic Surgery, 87 (6), 1993 - 2002.
Fleischer, D., Overholt, B., Sharma, V., Reymunde, A., Kimmey, M., Chuttani, R., et al. (2010) Endoscopic radiofrequency ablation for Barrett’s esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy, 42 (10), 781-789. (Level 4 Evidence - Industry sponsored)
National Comprehensive Cancer Network. (2011). NCCN clinical practice guidelines in oncology™. Esophageal and esophagogastric junction cancers. Retrieved June 9, 2011 from: http://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf.
National Institute for Health and Clinical Excellence. (2010, August). Ablative therapy for the treatment of Barrett’s oesophagus. Retrieved June 9, 2011 from: http://www.nice.org.uk/nicemedia/live/13096/50243/50243.pdf.
National Institute for Health and Clinical Excellence. (2010, May). Epithelial radiofrequency ablation for Barrett’s oesophagus. Retrieved June 9, 2011 from http://www.nice.org.uk/nicemedia/live/11359/48933/48933.pdf.
Pouw, R., Gondrie, J., Sondermeijer, C., ten Kate, F., van Gulik, T., Krishnadath, K., et al. (2008). Eradication of Barrett esophagus with early neoplasia by radiofrequency ablation, with or without endoscopic resection. Journal of Gastrointestinal Surgery, 12 (10), 1627 - 1636. (Level 4 Evidence – Industry sponsored)
Shaheen, N., Sharma, P., Overholt, B., Wolfsen, H., Sampliner, R., Wang, K, et al. (2009). Radiofrequency ablation in Barrett’s esophagus with dysplasia. New England Journal of Medicine, 360 (22), 2277 - 2288. (Level 2 Evidence - Industry Supported)
Sharma, V., Wang, K., Overholt, B., Lightdale, C., Fennerty, M., Dean, P., et al. (2007). Balloon-based, circumferential, endoscopic radiofreqency ablation of Barrett’s esophagus: 1-year follow-up of 100 patients. Gastrointestinal Endoscopy, 65 (2), 185 - 195. (Level 4 Evidence - Industry sponsored)
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Guidelines for Surgical Treatment of Gastroesophageal Reflux Disease. Retrieved June 9, 2011 from http://www.sages.org/publication/id/22/.
Spechler, S., Sharma, P., Souza, R., Inadomi, J., Shaheen, N., Allen, J., et al. (2011) American Gastroenterological Association medical position statement on the management of Barrett’s esophagus. Gastroenterology, 140 (3), 1084-1091.
Technology Evaluation Center. (2010, November). Radiofrequency ablation of nondysplastic or low-grade dysplastic Barrett’s Esophagus. (Vol. 25, No. 5). Retrieved June 9, 2011 from http://www.bcbs.com/blueresources/tec/press/radiofrequency-ablation-nondysplastic.html. (30 articles and/or guidelines reviewed)
U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060169. Retrieved June 9, 2011 from: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060169.pdf.
U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051168. Retrieved June 8, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051168.pdf.
U.S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072651. Retrieved June 8, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072651.pdf.
Wani, S., Falk, G., Hall, M., Gaddam, S., Wang, A., Gupta, N., et al. (2011). Patients with nondysplastic Barrett’s esophagus have low risks for developing dysplasia or esophageal adenocarcinoma. Clinical Gastroenterology and Hepatology, 9 (3), 220-227. (Level 2 Evidence - Independent)
Wani, S., Puli, S., Shaheen, N., Westhoff, B., Slehria, S., Bansal, A., et al. (2009) Esophageal adenocarcinoma in Barrett’s esophagus after endoscopic ablative therapy: A meta-analysis and systemic review. The American Journal of Gastroenterology. 104 (2), 502-513.
ORIGINAL EFFECTIVE DATE: 10/9/2010
MOST RECENT REVIEW DATE: 12/10/2011
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