This article will appear in the upcoming July-August print issue of Surgical Products.
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Barrett's esophagus (BE), an increasingly significant clinical condition in which metaplastic columnar epithelium replaces the normal distal esophageal squamous mucosa, is a complication of gastroesophageal reflux disease (GERD). (1) Left untreated, BE can lead to esophageal adenocarcinoma, one of the most rapidly increasing cancers in the United States, which carries a five-year overall survival rate of less than 15 percent. (2) The use of proton pump inhibitors (PPIs) would be expected to prevent this cancer because it heals reflux esophagitis, and reduces esophageal acid exposure preventing acid-induced proliferation and cancer-promoting cytokine secretion by esophageal epithelial cells. Unfortunately, several studies have failed to show any PPI-induced cancer protection. In fact, in a recent study, high-adherence and long-term PPI use was associated with a significantly increased risk of high-grade dysplasia and adenocarcinoma. (3)
Over the past 15 years, the utilization of radiofrequency (RF) ablation (HALO procedure) has become the standard in the treatment of BE by creating superficial necrosis of the metaplastic and dysplastic tissue and has been proven highly effective with 98.4 percent of patients BE-free at 30-month follow up.(4) However, the treatment of BE does not end at clearing the pre-cancerous tissue. There needs to be an intervention to reduce the likelihood if it from returning. Currently the standard to prevent recurrence of BE is similar to the first line of defense for GERD – a regimen of PPI. However, if a PPI regimen was initially unable to prevent reflux, it seems unlikely to prevent recurrence of BE. Further, even twice daily PPI therapy frequently fails to control esophageal acid exposure. (5)
Stretta is a non-ablative RF treatment that remodels the musculature of the lower esophageal sphincter (LES) and gastric cardia to significantly improve the antireflux barrier and reduce the frequency of transient lower sphincter relaxations (tLESRs) and reflux events. Stretta has been shown to be safe and clinically effective in more than 33 studies, demonstrating lasting symptom relief for up to 10 years. (6) In patients with GERD, Stretta has been shown to eliminate or significantly reduce the need for long-term medication use, and therefore may also provide the necessary intervention to prevent recurrence of BE in select patients. In a long-term cohort study of patients treated with Stretta for GERD, 33 patients had prior BE defined as positive metaplasia on four quadrant biopsies and one had low-grade dysplasia. At 10-year follow-up, only five of the 33 had any remaining metaplasia noted in biopsies. The one patient with low-grade dysplasia had no further dysplasia or metaplasia. (7)
A theoretical argument can be made about why Stretta should be better than medical therapy for BE and esophageal cancer prevention. PPI therapy exclusively targets gastric acid production, but acid is not the only potentially harmful agent in the refluxate. An effective Stretta stops the reflux of all noxious refluxed material, including the potentially carcinogenic bile acids, while it obviates the potential side effects of PPIs. Combined with HALO ablation, Stretta could be a non-pharmacologic, non-surgical alternative as a BE elimination strategy. Unfortunately, such dual approach has not been explored in clinical trials. Appropriate patient selection is important and likely candidates would be those with short-segment BE and without significant hiatal hernia.
A potential progression of complete care for a BE patient could consist of the following: Assessment of BE and GERD for feasibility of Stretta. If no hiatal hernia is present or if hiatal hernia is less than two centimeters in length, Stretta first treats the underlying LES muscle improving the barrier function and thereby protecting the mucosal surface from further damage that leads to BE, as well as reducing reliance on PPIs. HALO then eradicates the BE tissue on the mucosal surface. Endoscopic mucosal resection (EMR) may or may not be used in conjunction with HALO to treat nodular disease. Follow-up impedance/pH testing is then performed to ascertain control of both acid and non-acid reflux. Such optimized combination strategy may reduce cancer development while GERD remains controlled.
1. Spechler SJ: Barrett esophagus and risk of esophageal cancer: a clinical review. JAMA 2013;310: 627-636.
2. American Cancer Society. Cancer Facts & Figures 2014. http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf. Accessed April 1, 2014.
3. Hvid-Jensen F, Pedersen L, Funch-Jensen P, Drewes AM. Proton pump inhibitor use may not prevent high-grade dysplasia and oesophageal adenocarcinoma in Barrett's oesophagus: a nationwide study of 9883 patients. Aliment Pharmacol Ther. 2014; 39:984-91.
4. Fleischer DE, Overholt BF, Sharma VK, et al. Endoscopic radiofrequency ablation for Barrett's esophagus: 5-year outcomes from a prospective multicenter trial. Endoscopy. 2010;42:781-89
5. Ouatu-Lascar R, Triadafilopoulos G. Complete elimination of reflux symptoms does not guarantee normalization of intraesophageal acid reflux in patients with Barrett's esophagus. Am J Gastroenterol. 1998 May;93(5):711-6.
6. Auyang ED, Carter P, Rauth T, Fanelli RD. SAGES clinical spotlight review: endoluminal treatments for gastroesophageal reflux disease (GERD). Surgical Endoscopy. August 2013, Volume 27, Issue 8, pp 2658-2672
7. Noar M, Squires P, Noar E, Lee M. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surgical Endoscopy. 2014 Feb 22. [Epub ahead of print]