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Original Investigation |

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

K. Nadine Phoa, MD1; Frederike G. I. van Vilsteren, MD1; Bas L. A. M. Weusten, MD2; Raf Bisschops, MD3; Erik J. Schoon, MD4; Krish Ragunath, MD5; Grant Fullarton, MD6; Massimiliano Di Pietro, MD7; Narayanasamy Ravi, MD8; Mike Visser, MD9 ; G. Johan Offerhaus, MD9 ; Cees A. Seldenrijk, MD10 ; Sybren L. Meijer, MD9 ; Fiebo J. W. ten Kate, MD9 ; Jan G. P. Tijssen, PhD11 ; Jacques J. G. H. M. Bergman, MD, PhD1
[+] Author Affiliations
1Department of Gastroenterology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
2Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands
3Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium
4Department of Gastroenterology, Catharina Hospital, Eindhoven, the Netherlands
5Department of Gastroenterology, Queens Medical Center, Nottingham, England
6Department of Surgical Gastroenterology, Glasgow Royal Infirmary, Glasgow, Scotland
7Medical Research Council, Cancer Unit, Addenbrookes Hospital, Cambridge, England
8Department of Clinical Medicine and Gastroenterology, St James’s Hospital, Dublin, Ireland
9 Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
10 Department of Pathology, St Antonius Hospital, Nieuwegein, the Netherlands
11 Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
JAMA. 2014;311(12):1209-1217. doi:10.1001/jama.2014.2511.
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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 < .001) and the risk of progression to adenocarcinoma by 7.4% (1.5% for ablation vs 8.8% for control; 95% CI, 0%-14.7%; P = .03). Among patients in the ablation group, complete eradication occurred in 92.6% for dysplasia and 88.2% for intestinal metaplasia compared with 27.9% for dysplasia and 0.0% for intestinal metaplasia among patients in the control group (P < .001). Treatment-related adverse events occurred in 19.1% of patients receiving ablation (P < .001). The most common adverse event was stricture, occurring in 8 patients receiving ablation (11.8%), all resolved by endoscopic dilation (median, 1 session). The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued.

Conclusions and Relevance  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.

Trial Registration  trialregister.nl Identifier: NTR1198

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Figure 1.
Endoscopic Images From Patients With Barrett Esophagus and Low-Grade Dysplasia From Baseline Endoscopy and During and After Radiofrequency Ablation

A, Endoscopic image showing the distal esophagus at the baseline endoscopy, looking toward the gastroesophageal junction. The Barrett epithelium is characterized by its salmon-colored appearance on endoscopy compared with the pale appearance of the normal squamous mucosa. B, A deflated circumferential radiofrequency ablation balloon (extending from the device on the right) is positioned in the segment of Barrett esophagus. The immediate treatment effect of the circumferential ablation can be seen as the whitish discoloration. C, The focal radiofrequency ablation device visible at the top of the image is used for targeted ablation of a small area. The immediate treatment effect is visible as whitish discoloration in the middle and at the bottom of the image of residual Barrett epithelium. D, Endoscopic photograph showing the distal esophagus after complete eradication of all Barrett epithelium. Images are not from the same patient.

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Figure 2.
Enrollment and Outcomes
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Figure 3.
Occurrence of Progression to High-Grade Dysplasia or Adenocarcinoma
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