SAN DIEGO — Interim results from a randomized, controlled trial suggest that radiofrequency ablation is more effective than frequent surveillance for Barrett's esophagus.
The study compared 84 patients who underwent ablation with 43 who underwent a sham operation. All of the patients received high-dose acid suppression (40 mg esomeprazole twice daily). The ablation patients with high-grade dysplasia underwent endoscopic biopsies at 3, 6, 9, and 12 months, whereas those with low-grade dysplasia underwent endoscopic biopsies at 6 and 12 months, Dr. Nicholas Shaheen said at the annual Digestive Disease Week.
At the end of that time, 80% of the ablation patients with high-grade dysplasia and 90% of those with low-grade dysplasia experienced a complete response, defined as having all biopsies free of any histologic evidence of dysplasia, said Dr. Shaheen of the University of North Carolina, Chapel Hill.
In contrast, 26% of the control patients experienced a complete response. The difference between the ablation and control patients was statistically significant in the intent-to-treat analysis.
Of the patients who underwent ablation, 77% experienced a complete response for intestinal metaplasia, compared with none of the control patients. This difference also was statistically significant.
There was also a significant difference in the rate of histologic progression from low-grade dysplasia to high-grade dysplasia, and from high-grade dysplasia to cancer. Of those receiving a sham operation, 19% experienced progression of the disease, compared with 5% of the ablated patients.
Adverse events were relatively minor. Of the ablated patients, 6% experienced strictures, but all resolved after a mean of two dilations. There were three serious adverse events in the ablated patients and none in those who received a sham operation. One patient experienced an upper GI bleed, and two others experienced chest pain and were admitted overnight for observation.
“Patients often do have chest pain after the procedure,” Dr. Shaheen said in an interview. “This pain is usually mild to moderate, and was managed successfully in 295 of the 297 procedures performed in the trial with oral pain medications or no medications. Two patients had to be admitted for chest pain.”
The study, which is ongoing, is being conducted at 19 medical centers in the United States. It was funded by BÂRRX Medical Inc., which manufactures the radiofrequency ablation system used in the study. Dr. Shaheen said she received “other financial benefits” from that company, as well as consulting fees, speaking fees, research support, and/or other financial benefits from AstraZeneca Pharmaceuticals LP, TAP Pharmaceutical Products Inc., Procter & Gamble Co., Eisai Co., Merck & Co., and Ethicon Endo-Surgery Inc.
Endoscopic view of a Barrett's esophagus patient after radiofrequency ablation. Courtesy Dr. Nicholas Shaheen