U.K. data confirm efficacy of RFA for Barrett's esophagus

Data from a U.K. registry reveal that 86% of Barrett’s esophagus patients achieve complete remission of high-grade dysplasia after radiofrequency ablation, with only 9% reporting adverse events.

"The safety and short-term efficacy of radiofrequency ablation as a minimally invasive intervention for premalignant dysplastic Barrett’s esophagus are now beyond debate," wrote Dr. Rehan J. Haidry and his coauthors in the July issue of Gastroenterology (doi: 10.1053/j.gastro.2013.03.045).

Indeed, radiofrequency ablation (RFA) "has provided clinicians in specialist centers a valuable adjunct to more established surgical treatments."

Dr. Haidry, of the National Medical Laser Centre at University College London, and his colleagues analyzed data from the U.K. National Halo RFA Registry, founded in 2008 to audit outcomes of all patients undergoing ablation using the Halo device for high-grade dysplasia and early cancer in Barrett’s esophagus.

The cohort included 335 patients (mean age, 68.1 years); 81% were men and 100% were white.

Dr. Haidry calculated that the median number of RFA treatments was 2 (range, 1-6), and they took place over a median period of 11.6 months. The mean length of Barrett’s esophagus to be ablated was 5.8 cm. In all, 72% of patients were classed as having high-grade dysplasia, 24% as having low-grade dysplasia, and 4% as having intramucosal cancer.

About half the patients (49%) underwent endoscopic resection before starting RFA.

The researchers then combed the records for evidence of the primary outcomes of this analysis: complete reversal of high-grade dysplasia and complete reversal of all dysplasia 12 months from the index RFA treatment.

They found that at 1 year post RFA, 86% of patients had achieved complete reversal of high-grade dysplasia, and 81% showed complete reversal of all dysplasia.

Nevertheless, the authors also found 12 cases of recurrent neoplasia after "apparently successful" ablation, occurring at a mean 8 months after completion of the protocol.

Additionally, "5.1% have progressed to invasive disease at their most recent follow-up biopsy," the authors wrote.

Looking at the safety profile of RFA, the investigators uncovered one case of perforation in a patient who was treated with a 34-mm balloon (since removed from the market, according to the researchers), and 30 cases (9%) of stricturing, all of which were managed endoscopically.

The authors conceded several limitations to this "real world" analysis of what they called "the largest series to date of patients with early Barrett’s neoplasia undergoing RFA."

For example, "the proposed protocol states that all patients should undergo ablation every 3 months until the 12-month period, at which point the end-of-protocol biopsy defines treatment success or failure," wrote Dr. Haidry.

"Within the confines of varied practice nationwide and diversity in resources, these strict timelines were difficult to achieve."

Moreover, "although the durability of favorable response appears promising, our median follow-up time of 19 months is short," added the authors, noting that two late relapses occurred more than 4 years after "apparently successful" ablation.

"This highlights the importance of long-term follow-up of these patients."

The researchers disclosed that one of their coauthors has financial ties to the makers of the Halo device. The work was supported by the Cancer Research UK (CRUK) University College London Early Cancer Medicine Centre, and was conducted at a facility sponsored by the U.K. Department of Health.