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Previous Volume 360:2277-2288 May 28, 2009 Number 22 Next

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ABSTRACT

Background Barrett's esophagus, a condition of intestinal metaplasia of the esophagus, is associated with an increased risk of esophageal adenocarcinoma. We assessed whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett's esophagus and decrease the rate of neoplastic progression.

Methods In a multicenter, sham-controlled trial, we randomly assigned 127 patients with dysplastic Barrett's esophagus in a 2:1 ratio to receive either radiofrequency ablation (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of Barrett's esophagus. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia.

Results In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, as compared with 22.7% of those in the control group (P<0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0% of those in the ablation group, as compared with 19.0% of those in the control group (P<0.001). Overall, 77.4% of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3% of those in the control group (P<0.001). Patients in the ablation group had less disease progression (3.6% vs. 16.3%, P=0.03) and fewer cancers (1.2% vs. 9.3%, P=0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients (6.0%) had esophageal stricture.

Conclusions In patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression. (ClinicalTrials.gov number, NCT00282672 [ClinicalTrials.gov] .)

Source Information

The authors' affiliations are listed in the Appendix.

Address reprint requests to Dr. Shaheen at the Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, CB 7080, Chapel Hill, NC 27599-7080, or at nshaheen{at}med.unc.edu.

Full Text of this Article

Related Letters:

Radiofrequency Ablation in Barrett's Esophagus
Ell C., Pech O., May A., Stolte M., Shaheen N. J., Madanick R. D., Fleischer D. E.
Extract | Full Text | PDF  
N Engl J Med 2009; 361:1021-1022, Sep 3, 2009. Correspondence

This article has been cited by other articles:

• Ell, C., Pech, O., May, A., Stolte, M., Shaheen, N. J., Madanick, R. D., Fleischer, D. E. (2009). Radiofrequency Ablation in Barrett's Esophagus. NEJM 361: 1021-1022 [Full Text]  
• (2009). All you need to read in the other general journals. BMJ 338: b2196-b2196 [Full Text]  
• Bergman, J. J.G.H.M. (2009). Radiofrequency Ablation -- Great for Some or Justified for Many?. NEJM 360: 2353-2355 [Full Text]  
• (2009). Radiofrequency Ablation Therapy for BE with Dysplasia. JWatch Gastroenterology 2009: 1-1 [Full Text]