BlueCross BlueShield of Tennessee Medical Policy Manual

Ablation Treatments for Barrett’s Esophagus

DESCRIPTION

Barrett’s esophagus (BE) is a condition in which the normal squamous epithelium is replaced by specialized columnar-type epithelium, known as intestinal metaplasia. Intestinal metaplasia is a precursor to adenocarcinoma.  These metaplastic changes can be triggered by the inflammation and injury caused by chronic gastroesophageal reflux or chronic esophagitis and is 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 (e.g., Barrx™ 360 RFA Balloon Catheter or Barrx™ 90 RFA Focal Catheter), a treatment for Barrett’s esophagus, uses bipolar electrodes and an ablation catheter or balloon to rapidly deliver radiofrequency energy to the dysplastic tissue. All the identified diseased tissue of the superficial epithelium is ablated or destroyed and removed without damaging the submucosa. The goal of treatment is eradication of dysplastic cells to reduce the risk for neoplastic progression or development of adenocarcinoma of the esophagus.

Cryotherapy (e.g., CryoSpray Ablation™ System) 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. Dis-advantages include the uneven application of the cryogen spray.

POLICY

See also:

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

For patients with non-dysplastic Barrett’s esophagus, it cannot be concluded that the benefit of RFA outweighs the risk, and therefore RFA is considered investigational. Data for the efficacy of cryoablation of BE with or without dysplasia are limited. The studies consist of small numbers of patients with short-term follow-up, and therefore, cryoablation of Barrett’s esophagus is considered investigational.

SOURCES

American College of Gastroenterology. (2015). ACG clinical guideline: diagnosis and management of Barrett’s esophagus. Retrieved December 14, 2016 from http://gi.org/wp-content/uploads/2015/11/ACG-2015-Barretts-Esophagus-Guideline.pdf.

American Gastroenterological Association. (2015). Quality indicators for the management of Barrett’s esophagus, dysplasia and esophageal adenocarcinoma: international consensus recommendations from the American gastroenterological association symposium. Retrieved December 14, 2016 from http://www.gastrojournal.org/article/S0016-5085(15)01145-2/.

American Gastroenterological Association. (March 2011) American Gastroenterological Association medical position statement on the management of Barrett's esophagus. Retrieved December 14, 2016 from http://www.gastrojournal.org/article/S0016-5085(11)00084-9/pdf.

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2016). Endoscopic radiofrequency ablation or cryoablation for Barrett’s esophagus (2.01.80). Retrieved December 14, 2016 from BlueWeb. 48 articles and/or guidelines reviewed)

Chadwick, G., Groene, O., Markar, S., Hoare, J., Cromwell, D., & Hanna, G. (2014). Systematic review comparing radiofrequency ablation and complete endoscopic resection in treating dysplastic Barrett’s esophagus: a critical assessment of histologic outcomes and adverse events. Gastrointestinal Endoscopy, 79 (5), 718-731. Abstract retrieved December 14, 2016 from PubMed database.

Desai, M., Saligram, S., Gupta, N., Vennalaganti, P., Bansal, A., Choudhary, A., et al. (2016). Efficacy and safety outcomes of multimodal endoscopic eradication therapy in Barrett’s esophagus-related neoplasia: a systematic review and pooled-analysis. Gastrointestinal Endoscopy, 2016 Sep 23. (Epub ahead of print). Abstract retrieved December 14, 2016 from PubMed database.

National Comprehensive Cancer Network. (2016). NCCN clinical practice guidelines in oncology (NCCN Guidelines®) Esophageal and esophagogastric junction cancers. Version 2.2016. Retrieved December 14, 2016 from the National Comprehensive Cancer Network.

National Institute for Health and Clinical Excellence. (2010). Barrett’s oesophagus: ablative therapy. Retrieved December 14, 2016 from: www.nice.org.uk/guideance3/cg106

National Institute for Health and Clinical Excellence. (2014). Endoscopic radiofrequency ablation for Barrett’s oesophagus with low-grade dysplasia or no dysplasia. Retrieved December 14, 2016 from www.nice.org.uk/guidance/ipg496.

Orman, E., Li, N., & Shaheen, N. (2013). Efficacy and durability of radiofrequency ablation for Barrett’s esophagus: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology, 2013, 11, 1245-1255. (Level 2 evidence)

Phoa, N., et al. (March 2014) Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. Journal of American Medical Association. 311(12):1209-1217. (Level 2 evidence)

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., Rubenstein, J., Vieth, M.,& Bergman, J. (2016). Diagnosis and management of low-grade dysplasia in Barrett’s esophagus: clinical practice updates expert review from the clinical guidelines committee of the American Gastroenterological Association. Gastroenterology, 2016 Oct 1. (Epub ahead of print). Abstract retrieved December 14, 2016 from PubMed database.

ORIGINAL EFFECTIVE DATE:  10/9/2010

MOST RECENT REVIEW DATE:  1/12/2017

ID_BT

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