Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

BACKGROUND & AIMS Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE. METHODS We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events. RESULTS After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years). CONCLUSIONS In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.

[1]  Paul Fockens,et al.  Efficacy of radiofrequency ablation combined with endoscopic resection for barrett's esophagus with early neoplasia. , 2010, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[2]  P. Mavrelis,et al.  Radiofrequency ablation of Barrett’s esophagus: outcomes of 429 patients from a multicenter community practice registry , 2010, Endoscopy.

[3]  G. Triadafilopoulos,et al.  Efficacy of esomeprazole in controlling reflux symptoms, intraesophageal, and intragastric pH in patients with Barrett's esophagus. , 2003, Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus.

[4]  Amy Linsky,et al.  Proton pump inhibitors and risk for recurrent Clostridium difficile infection. , 2010, Archives of internal medicine.

[5]  Kenneth K Wang,et al.  Updated Guidelines 2008 for the Diagnosis, Surveillance and Therapy of Barrett's Esophagus , 1998, The American Journal of Gastroenterology.

[6]  S. Hennessy,et al.  Proton-Pump Inhibitor Use and the Risk for Community-Acquired Pneumonia , 2008, Annals of Internal Medicine.

[7]  N. Soehendra,et al.  Stepwise radical endoscopic resection versus radiofrequency ablation for Barrett's oesophagus with high-grade dysplasia or early cancer: a multicentre randomised trial , 2011, Gut.

[8]  Ananya Das,et al.  Circumferential and Focal Ablation of Barrett's Esophagus Containing Dysplasia , 2009, The American Journal of Gastroenterology.

[9]  A. Sonnenberg,et al.  Long-term nonsurgical management of Barrett's esophagus with high-grade dysplasia. , 2001, Gastroenterology.

[10]  D. Corley,et al.  Proton pump inhibitors and histamine-2 receptor antagonists are associated with hip fractures among at-risk patients. , 2010, Gastroenterology.

[11]  S. Suissa,et al.  Proton pump inhibitor use and risk of community-acquired Clostridium difficile-associated disease defined by prescription for oral vancomycin therapy , 2006, Canadian Medical Association Journal.

[12]  Kenneth K Wang,et al.  Long-term survival following endoscopic and surgical treatment of high-grade dysplasia in Barrett's esophagus. , 2007, Gastroenterology.

[13]  Michael D Howell,et al.  Acid-suppressive medication use and the risk for hospital-acquired pneumonia. , 2009, JAMA.

[14]  G. Triadafilopoulos,et al.  Oesophageal and gastric pH profiles in patients with gastro‐oesophageal reflux disease and Barrett's oesophagus treated with proton pump inhibitors , 2004, Alimentary pharmacology & therapeutics.

[15]  D. Fleischer,et al.  A prospective pilot trial of ablation of Barrett's esophagus with low-grade dysplasia using stepwise circumferential and focal ablation (HALO system). , 2008, Endoscopy.

[16]  P. Fockens,et al.  Eradication of Barrett Esophagus with Early Neoplasia by Radiofrequency Ablation, with or without Endoscopic Resection , 2008, Journal of Gastrointestinal Surgery.

[17]  Yu-Xiao Yang,et al.  Long-term proton pump inhibitor therapy and risk of hip fracture. , 2006, JAMA.

[18]  P. Fockens,et al.  Stepwise circumferential and focal ablation of Barrett’s esophagus with high-grade dysplasia: results of the first prospective series of 11 patients , 2008, Endoscopy.

[19]  J K Greenson,et al.  Reproducibility of the diagnosis of dysplasia in Barrett esophagus: a reaffirmation. , 2001, Human pathology.

[20]  N. Shaheen,et al.  A cost-utility analysis of ablative therapy for Barrett's esophagus. , 2009, Gastroenterology.

[21]  R. K. Pearson.  Radiofrequency Ablation in Barrett's Esophagus with Dysplasia , 2009 .

[22]  Kenneth J. Chang,et al.  Circumferential ablation of Barrett's esophagus that contains high-grade dysplasia: a U.S. Multicenter Registry. , 2008, Gastrointestinal endoscopy.

[23]  Kenneth J. Chang,et al.  Endoscopic radiofrequency ablation for Barrett’s esophagus: 5-year outcomes from a prospective multicenter trial* , 2010, Endoscopy.

[24]  P. Fockens,et al.  What Are the Outcomes of Endoscopic Radiofrequency Ablation for Very Long Segments of Barrett Esophagus Containing Neoplasia , 2009 .

[25]  M. Vieth,et al.  Properties of the Neosquamous Epithelium After Radiofrequency Ablation of Barrett's Esophagus Containing Neoplasia , 2009, The American Journal of Gastroenterology.