Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up

Background: For patients with Barrett's esophagus because of an elevated risk for developing dysplasia therapies have been used to eradicate BE. Recently with encouraging short-term results. (BE), life-long surveillance endoscopy is recommended and esophageal adenocarcinoma. Various endoscopic circumferential radiofrequency ablation has been used with encouraging short-term results. Objective: To provide longer follow-up and to assess the long-term safety and efficacy of step-wise circumferential ablation with the addition of focal ablation for BE. Design: Prospective, multicenter clinical trial (NCT00489268). Setting: Eight U.S. centers, between May 2004 and February 2007. Patients: Seventy subjects with 2 to 6 cm of BE and histologic evidence of intestinal metaplasia (IM). Interventions: circumferential ablation was performed at baseline and repeated at 4 months if there was residual IM. Follow-up biopsy specimens were obtained at 1, 3, 6, 12, and 30 months. Specimens were reviewed by a central pathology board. Focal ablation was performed after the 12-month follow-up for histological evidence of IM at the 12-month biopsy (absolute indication) or endoscopic appearance suggestive of columnar-lined esophagus (relative indication). Subjects received esomeprazole for control of esophageal reflux. Main outcome measurements: Complete absence of IM per patient from biopsy specimens obtained at 12 and 30 months, defined as complete remission-IM (CR-IM). Results: At 12 months, CR-IM was achieved in 48 of 69 available patients (70% per protocol [PP], 69% intention to treat [ITT]). At 30 months after additional focal ablative therapy, CR-IM was achieved in 60 of 61 available patients (98% PP, 97% ITT). There were no strictures or buried glandular mucosa detected by the standardized biopsy protocol at 12 or 30 months, and there were no serious adverse events. Limitations: This was an uncontrolled clinical trial with 2.5-year follow-up. Conclusion: Stepwise circumferential and focal ablation resulted in complete eradication of IM in 98% of patients at 2.5-year follow-up. (Gastrointest Endosc 2008;68:867-76.)