Radiofrequency Ablation Effective for Barrett's Oesophagus: Presented at DDW

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Title: Radiofrequency Ablation Effective for Barrett's Oesophagus: Presented at DDW
URL: http://www.pslgroup.com/dg/221B5A.htm
Doctor's Guide
May 21, 2008

By Ed Susman

SAN DIEGO -- May 21, 2008 -- Radiofrequency ablation of Barrett's oesophagus provides a high rate of success in destroying inappropriate tissue and enhances healing far better than a sham procedure.

"We didn't expect that the sham treatment would change anything about the cells in the oesophagus, but we are studying several other outcomes that could be affected by whether patients know they had or didn't have treatment," said Nicholas Shaheen, MD, Director, Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill, North Carolina.

The researchers screened 915 patients for the study, but Dr. Shaheen said most of these subjects decided they did not want to risk being in the placebo arm of the study and declined to participate. Dr. Shaheen reported on 101 of the patients who completed the 1-year study out of 127 who were treated in the study.

The sham patients tended to progress to hyperplasia and cancer, while in general the patients who had the ablation procedure were virtually free of metaplasia cells. Complete elimination of metaplasia was the rigourous standard for a successful procedure, Dr. Shaheen said in his oral presentation here on May 19 at Digestive Diseases Week 2008 (DDW).

In the intention-to-treat analysis, complete response of dysplasia was achieved in 80% of the 84 patients randomised to receive actual treatment compared with 11% of the 43 patients who received the sham treatment (P < .001). In those patients who actually received treatment -- the on-protocol group -- 905 of those who had the ablation procedure were free of dysplasia compared with 12% of the sham group (P < .001).

Complete response to metaplasia was achieved by 77% of the patients assigned to the radiofrequency arm of the study compared with none of the sham patients in the intention-to-treat analysis (P < .001). Of the patients who underwent the ablation treatment, 83% had no residual metaplasia compared with none of the patients in the sham arm of the study (P < .001).

All patients were prepared for treatment using the same approach, which included antacid therapy, and all patients had the ablation device inserted into the oesophagus. The research team called the central office to determine if the device should be activated.

Funding for this study was provided by BARRX Medical, Inc., and the investigator-sponsored support programs of AstraZeneca.

[Presentation title: A Randomized, Multicenter, Sham-Controlled Trial of Radiofrequency Ablation for Subjects With Barrett's Esophagus Containing Dysplasia: Interim Results of the AIM Dysplasia Trial. Abstract 213]

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