Gastroenterology

Gastroenterology

Volume 141, Issue 2, August 2011, Pages 460-468
Gastroenterology

Original Research
Clinical—Alimentary Tract
Durability of Radiofrequency Ablation in Barrett's Esophagus With Dysplasia

Presented in part at Digestive Diseases Weeks, 2008, 2009, and 2010.
https://doi.org/10.1053/j.gastro.2011.04.061Get rights and content

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.

Section snippets

Study Design

Participants were recruited at 19 US sites. Subjects were aged 18 to 80 years, and had endoscopically evident, non-nodular, dysplastic BE ≤8 cm in length confirmed by a central pathology laboratory. For subjects with HGD, we additionally required an endoscopic ultrasound negative for lymphadenopathy or esophageal wall abnormalities within 12 months of enrollment. Previous EMR was permissible ≥8 weeks before entry, provided that subsequent endoscopy demonstrated non-nodular dysplasia. Exclusion

Enrollment and Characteristics of Subjects Undergoing Treatment

Of 755 subjects screened, 127 (64 LGD, 63 HGD) were randomized (84 RFA, 43 SHAM) and 117 (78 RFA, 39 SHAM) completed 1-year follow-up, as reported previously.7 After reaching the 1-year primary end point, 35 of 39 subjects from SHAM were eligible for cross-over to RFA treatment and all elected to receive treatment. The remaining 4 of 39 developed EAC before the 1-year primary outcomes and were not eligible for cross-over. In all, 119 subjects underwent RFA in this trial (84 RFA at study outset

Discussion

Endoscopic therapy of dysplastic BE with RFA has demonstrated a high rate of CE-D and CE-IM, with an acceptable side effect profile.4, 7 The most important remaining issues in this field are the durability of the treatment effect and the longer-term outcomes of therapy. Because durability of treatment effect is a determinant of the cost-effectiveness of the procedure,10 and because subjects with recurrent BE after RFA are presumably at continued risk for developing EAC, it is vital to know

Conclusions

Follow-up of the subjects from the AIM Dysplasia trial to an average of 3.05 years demonstrates that a high percentage of subjects with both low-grade and high-grade dysplasia retain complete eradication of dysplasia and intestinal metaplasia after treatment. Most subjects with recurrence of disease could again attain complete eradication of intestinal metaplasia with further treatment. Progression of disease was rare in subjects who underwent RFA treatment, and the rate of progression to EAC

Acknowledgments

Dr Shaheen had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis.

Clinical Trials Registry: (ClinicalTrials.gov NCT00282672).

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    This article has an accompanying continuing education activity on page e13. Learning Objective: Upon completion of this activity, the successful learner will be able to describe the durability, safety and efficacy of radiofrequency ablation for dysplastic Barrett's esophagus.

    Conflicts of interest The authors disclose the following: Drs Chang and Lightdale received additional grant support from BÂRRX Medical. Drs Chang, Infantolino, and Lightdale received consulting fees from BÂRRX Medical. Drs Chang, Edmundowicz, Infantolino, Madanick, Muthasamy, and Overholt received lecture fees from BÂRRX Medical. Dr Chang has equity ownership in BÂRRX Medical and received consulting fees from BÂRRX Medical and royalties from the BÂRRX Medical Halo 90 device. Drs Eisen, Falk, Hoffman, Shaheen, Spechler, and Souza received grant support from AstraZeneca. Drs Eisen, Falk, Fennerty, Infantolino, Lightdale, Shaheen, Sharma, Souza, and Spechler received consulting fees from AstraZeneca. Drs Eisen, Falk, Infantolino, Madanick, and Shaheen received lecture fees from AstraZeneca. Dr Edmundowicz received consulting fees from Boston Scientific. Dr Eisen received consulting fees from Pfizer and lecture fees from Takeda. Drs Eisen, Shaheen, and Spechler received grant support from Takeda. Drs Edmundowicz and Falk received consulting fees from Olympus. Drs Eisen and Hoffman received lecture fees from Given Imaging. Dr Falk received consulting fees from Nycomed and Ethicon Endosurgery. Drs Falk and Sharma report receiving grant support from Given Imaging. Dr Fennerty received consulting fees from Novartis and Merck. Dr Hoffman received grant support from Bristol Myers Squibb, Salix, Lantheus Medical Imaging, and Otsuka Medical Research. Drs Fennerty, Infantolino, and Sharma received consulting fees from Santarus. Dr Infantolino received lecture fees from Santarus, Abbott, UCB, Centocor, and CSA Medical. Dr Infantolino also received consulting fees from Abbott, UCB, and Centocor. Drs Infantolino and Shaheen received consulting fees from CSA Medical. Dr Shaheen received consulting fees from NeoGenomics. Dr Lightdale received grant support from Boston Scientific. Drs Sampliner, Shaheen, Sharma, Souza, and Spechler received consulting fees from TAP/Takeda. Dr Shaheen received grant support from CSA Medical and NeoGenomics. Dr Sharma received grant support from Olympus. Dr Jobe received grant support from EndoGastric Solutions. The remaining authors disclose no conflicts.

    Funding This study was supported by funding from BÂRRX Medical, Inc. Study medication was provided through the investigator-sponsored study program of AstraZeneca. Statistical analysis and data management were supported by NIH P30 DK034987.

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