Radiofrequency Ablation Reduces Risk of High-Grade Dysplasia and Adenocarcinoma vs Endoscopic Surveillance in Patients With Barrett’s Esophagus
Barrett’s esophagus with low-grade dysplasia increases risk of esophageal adenocarcinoma. In a European study reported in JAMA, Phoa et al assessed whether endoscopic radiofrequency ablation reduced the rate of neoplastic progression compared with endoscopic surveillance in patients with Barrett’s esophagus and low-grade dysplasia. Ablation was associated with significantly reduced risk of progression to high-grade dysplasia or adenocarcinoma and of progression to adenocarcinoma.
Study Details
In the trial, 136 patients with a confirmed diagnosis of Barrett’s esophagus containing low-grade dysplasia were randomly assigned at nine European sites between June 2007 and June 2011 to receive endoscopic treatment with radiofrequency ablation (n = 68) or endoscopic surveillance (control, n = 68). Ablation was performed with a balloon device for circumferential ablation of the esophagus or a focal device for targeted ablation, with a maximum of five sessions permitted.
The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma over 3-year follow-up.
The ablation and control groups were generally balanced for age (mean, 63 years in both), sex (81% and 90% men), white race (97% in both), body mass index (mean, 26.8 and 27.9 kg/m2), circumferential (mean, 2 cm in both) and maximum Barrett’s esophagus (mean, 4 cm in both), time since diagnosis of Barrett’s esophagus (mean, 5 and 7 years) and since diagnosis of dysplasia (mean, 1 and 2 years), number of prior Barrett surveillance endoscopies (mean, five in both) and surveillance endoscopies with dysplasia (mean, two in both), history of gastroesophageal reflux disease (91% and 96%), use of proton pump inhibitors (100% and 99%), and years of proton pump inhibitor use (mean, 8 and 9).
Reduced Risk
After median follow-up of 36 months, progression to high-grade dysplasia or adenocarcinoma had occurred in 1.5% of the ablation group vs 26.5% of the control group (P < .001), and adenocarcinoma had occurred in 1.5% vs 8.8% (P = .03). The number needed to treat to prevent one case of high-grade dysplasia or adenocarcinoma was 4.0, and the number needed to treat to prevent one case of adenocarcinoma was 13.6.
On review of the second planned interim analysis in April 2013, the data and safety monitoring board recommended early termination of the trial due to the superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued, and the steering committee closed the trial in May 2013.
Complete eradication occurred in 92.6% of patients for dysplasia and 88.2% for intestinal metaplasia by the end of endoscopic treatment in the ablation group, compared with 27.9% for dysplasia and 0.0% for intestinal metaplasia during follow-up among patients in the control group (P < .001). The ablation group underwent a total of 211 ablation sessions (median of 3 per patient) and 208 endoscopic biopsy sessions (median of 3 per patient, with a median of 37 biopsies per patient). The control group underwent a total of 227 endoscopy and biopsy sessions (median of 3 per patient, with a median of 32 biopsies per patient).
Adverse Events
Treatment-related adverse events occurred in 13 patients receiving ablation (19.1%) vs none of the control patients (P < .001). The most common adverse event in ablation patients was stricture requiring dilation (eight patients, 11.8%); in addition, three patients had small mucosal lacerations and one had retrosternal pain. Three serious adverse events occurred in two patients; one was hospitalized with abdominal pain 4 days after ablation, and one had bleeding after resection for a visible (low-grade) lesion prior to the first ablation and subsequently experienced stricture.
The investigators concluded, “In this randomized trial of patients with Barrett esophagus and a confirmed diagnosis of low-grade dysplasia, radiofrequency ablation resulted in a reduced risk of neoplastic progression over 3 years of follow-up.”
Jacques J. G. H. M. Bergman, MD, PhD, of Academic Medical Center Amsterdam, is the corresponding author for the JAMA article.
The study was supported by a grant from the Dutch Digestive Diseases Foundation and by Covidien GI Solutions. For full disclosures of the study authors, visit jama.jamanetwork.com.
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