Durability of radiofrequency ablation in Barrett's esophagus with dysplasia

Abstract

Background & aims: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE.

Methods: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events.

Results: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years).

Conclusions: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.

Trial registration: ClinicalTrials.gov NCT00282672.

Conflict of interest statement

The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis. Potential investigator conflicts of interest were disclosed to study participants. See disclosures page for full disclosure of potential conflicts of interest and funding sources for this study.

Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Flow Diagram of Subjects progressing through the trial. Cross-over to active therapy is represented by the arrows leading from the sham arm to active treatment.

Figure 2

Kaplan-Meier analysis of the durability of complete eradication of dysplasia. All subjects in this analysis achieved complete eradication of dysplasia at or after the 12 month endpoint (n=110), and time 0 for this analysis is the first finding of complete eradication of dysplasia at or after month 12. For purposes of this analysis, any recurrent dysplasia noted after initially achieving CE-D was considered a failure, even if such recurrence was followed by focal RFA and reestablishment of CE-D. HGD, High-grade dysplasia; LGD, Low-grade dysplasia.

Figure 3

Kaplan-Meier analysis of the durability of complete eradication of intestinal metaplasia. All subjects in this analysis achieved complete eradication of dysplasia at or after the 12 month endpoint (n=108), and time 0 for this analysis is the first finding of complete eradication of intestinal metaplasia at or after month 12. For purposes of this analysis, any recurrent intestinal metaplasia noted after initially achieving CE-IM was considered a failure, even if such recurrence was followed by focal RFA and reestablishment of CE-IM. HGD, High-grade dysplasia; LGD, Low-grade dysplasia; IM, intestinal metaplasia.