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RFA reported effective for Barrett’s esophagus patients with a prior fundoplication
SAN DIEGO — Radiofrequency ablation was reported to be safe and effective for Barrett’s esophagus with a prior fundoplication, yet prior fundoplication was not associated with improved efficacy or reduced number of ablation sessions compared with proton pump inhibitors, according to data presented at the 2012 Digestive Disease Week Annual Meeting.
To determine if ongoing acid and bile reflux impair healing and squamous re-epithelialization after treatment of Barrett’s esophagus with radiofrequency ablation (RFA) — and whether prior fundoplication improves subsequent safety and/or efficacy of ablation — researchers assessed data from a nationwide registry of patients treated with RFA for Barrett’s esophagus.
The U.S. RFA Registry is a prospective study of patients with BE treated with RFA at 148 institutions. Information collected in the registry includes demographic data, histology prior to treatment, endoscopic findings, date and number of treatment sessions, ablation outcomes, and complications.
The safety cohort consisted of all patients treated with RFA, while the efficacy cohort was limited to subjects who had biopsies ≥12 months after RFA treatment initiation. Complete eradication of intestinal metaplasia was achieved if the final biopsies demonstrated no intestinal metaplasia. Researchers also compared safety and efficacy outcomes between those with a history of fundoplication and those undergoing medical management, using parametric tests. Safety outcomes included rates of bleeding, stricture and hospitalization. Efficacy outcomes included complete eradication of intestinal metaplasia, complete eradication of dysplasia, and number of treatment sessions needed for complete eradication of intestinal metaplasia. Efficacy results are reported for the full cohort and stratified as non-dysplastic Barrett’s esophagus vs. dysplastic Barrett’s esophagus.
According to study results, of the 5,539 patients receiving RFA, 318 (5.7%) had a prior fundoplication. Of these patients, 0.9% developed stricture after RFA and 1.3% were hospitalized. There were no perforations or clinically significant bleeding in the fundoplication group. Rates of stricture, bleeding, and hospitalization were not statistically different (P>0.05) between patients with and without prior fundoplication. In all, 2,135 of 5,539 (39%) had biopsy data available after 12 months.
Complete eradication of intestinal metaplasia was achieved in 78% of patients with a fundoplication vs. 72% in those without fundoplication, while complete eradication of dysplasia was achieved in 93% of subjects with a fundoplication and 87% of those without a fundoplication (P>0.05 for both comparisons). Subjects with prior fundoplication had similar rates of complete eradication of dysplasia, complete eradication of intestinal metaplasia, and number of RFA sessions for eradication when compared to those without prior fundoplication.
“We were surprised that the answer to this question was no,” Nicholas Shaheen, MD, AGAF, director for the Center for Esophageal Diseases and Swallowing at the University of North Carolina, Chapel Hill said in a press release. “Whether patients were taking medicine or having the wrap, their changes of getting rid of precancerous cells was about the same, and their complication rate from the procedure was about the same.”
For more information:
- Shaheen H. #808: Prior Fundoplication Does Not Improve Subsequent Safety or Efficacy Outcomes of Radiofrequency Ablation (RFA): Results From the U.S. RFA Registry. Presented at: the 2012 Digestive Disease Week Annual Meeting; May 19-22, 2012; San Diego.