Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial

Phoa, K. Nadine; van Vilsteren, Frederike G.I.; Weusten, Bas L.A.M.; Bisschops, Raf; Schoon, Erik J.; Raganuth, Krish; Fullarton, Grant; Di Pietro, Massimiliano; Ravi, Narayanasamy; Visser, Mike; Offerhaus, G. Johan; Seldenrijk, Cees A.; Meijer, Sybren L.; ten Kate, Fiebo J.W.; Tijssen, Jan G.P.; Bergman, Jacques J.G.H.M.

Abstract

Importance
Barrett esophagus containing low-grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma, a cancer with a rapidly increasing incidence in the western world.

Objective
To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression.

Design, Setting, and Participants
Multicenter randomized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low-grade dysplasia at 9 European sites between June 2007 and June 2011. Patient follow-up ended May 2013.

Interventions
Eligible patients were randomly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation (ablation) or endoscopic surveillance (control). Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation, with a maximum of 5 sessions allowed.

Main Outcomes and Measures
The primary outcome was neoplastic progression to high-grade dysplasia or adenocarcinoma during a 3-year follow-up since randomization. Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events.

Results
Sixty-eight patients were randomized to receive ablation and 68 to receive control. Ablation reduced the risk of progression to high-grade dysplasia or adenocarcinoma by 25.0% (1.5% for ablation vs 26.5% for control; 95% CI, 14.1%-35.9%; P?

Citation

Phoa, K. N., van Vilsteren, F. G., Weusten, B. L., Bisschops, R., Schoon, E. J., Raganuth, K., Fullarton, G., Di Pietro, M., Ravi, N., Visser, M., Offerhaus, G. J., Seldenrijk, C. A., Meijer, S. L., ten Kate, F. J., Tijssen, J. G., & Bergman, J. J. (2014). Radiofrequency Ablation vs Endoscopic Surveillance for Patients With Barrett Esophagus and Low-Grade Dysplasia: A Randomized Clinical Trial. Journal of the American Medical Association, 311(12), 1209-1217. https://doi.org/10.1001/jama.2014.2511

• Journal Article Type: Article
• Acceptance Date: Feb 28, 2014
• Online Publication Date: Mar 26, 2014
• Publication Date: Mar 26, 2014
• Deposit Date: Feb 12, 2018
• Publicly Available Date: Dec 16, 2020
• Journal: Journal of the American Medical Association
• Print ISSN: 0098-7484
• Electronic ISSN: 1538-3598
• Publisher: American Medical Association
• Peer Reviewed: Peer Reviewed
• Volume: 311
• Issue: 12
• Pages: 1209-1217
• DOI: https://doi.org/10.1001/jama.2014.2511
• Public URL: https://nottingham-repository.worktribe.com/output/1118264
• Publisher URL: https://jamanetwork.com/article.aspx?doi=10.1001/jama.2014.2511
• PMID: 24668102