Original ResearchClinical—Alimentary TractDurability of Radiofrequency Ablation in Barrett's Esophagus With Dysplasia
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.