Balloon-based electrode for the ablation of non-dysplastic Barrett's esophagus: ablation of intestinal metaplasia (AIM II Trial).

INTRODUCTION: Barrett's esophagus (BE) is a condition in which an abnormal intestinal-type epithelium called specialized intestinal metaplasia (SIM) replaces the stratified squamous epithelium that normally lines the distal esophagus. This occurs as a consequence of chronic gastroesophageal reflux disease (GERD) which is present in more than 20% of adults. It is present in 1-2% of the United States population with an estimated prevalence as high as 25% in white males older than 50 yrs without GERD. This intestinal metaplasia predisposes patients to esophageal adenocarcinoma, the most rapidly rising tumor incidence over the last 30 years, with an annual incidence of 0.5% in patients with BE and a survival rate less than 10% in 5 years. The objective of the study was to assess the safety and efficacy of circumferential endoscopic ablation of Barrett's esophagus using the HALO360 System.

METHODS: Patients with non-dysplastic Barrett's esophagus confirmed within the previous year were treated twice per session with a balloon-based, bipolar radiofrequency ablation device with a pre selected energy of 10 J/ cm2 at 260 W for 10 secs, achieving full thickness ablation of epithelium followed by Omeprazole 40 mg PO BID for 1 month and then, daily. Patients were followed at 1, 3, 6 and 12 months with EGD with biopsy and a 2nd re treatment at 4 month if IM persisted.

RESULTS: A total of 21 Hispanic patients underwent treatment with a gender distribution of 9 female and 10 male, at a mean age of 59.6 years old (SD +/- 12.9) and a mean weight of 161 Lbs (SD +/- 26.1). There was a complete response of 66.7%, 61.9%, 76.2%, 76.2% at 1, 3, 6, and 12 month respectively and a biopsy clearance rate (BCR) of 84.6% and 92.3% at 6 and 12 mo with single treatment and of 62.5% and 50.0% at 6 and 12 month in retreated patients. No complications from the procedure such as strictures or ulcers were reported at 1 year after treatment.

CONCLUSIONS: In spite of the multiple treatment options for BE, especially among ablation techniques, radiofrequency ablation therapy is achieving promising results with a full thickness ablation of Barrett's epithelium in 76.2% of patients without direct injury to the submucosa, avoiding formation of strictures and minimal side effects from treatment.