A simplified regimen for focal radiofrequency ablation of Barrett's mucosa: a randomized multicenter trial comparing two ablation regimens

BackgroundThe currently recommended regimen for focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises 2 applications of energy, cleaning of the device and ablation zone, and 2 additional applications of energy. A simplified regimen may be of clinical utility if it is faster, easier, and equally safe and effective.ObjectiveTo compare the efficacy of 2 focal RFA regimens.SettingThree tertiary referral centers.PatientsConsecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled.InterventionsBE areas were paired: 1 area was randomized to the “standard” regimen (2 × 15 J/cm2–clean–2 × 15 J/cm2) or to the “simplified” regimen (3 × 15 J/cm2–no clean), allocating the second area automatically to the other regimen. The percentage of surface area regression of each area was scored at 2 months by the endoscopist (blinded).Outcome MeasureProportion of completely removed BE areas at 2 months. Calculated sample size was 46 pairs of BE areas using a noninferiority design. Noninferiority was defined as <20% difference in the paired proportions.ResultsForty-five equivalent pairs of BE areas were included in 41 patients. The proportion of completely removed BE areas at 2 months after focal RFA was 30 (67%) for standard and 33 (73%) for simplified. Noninferiority was demonstrated by a 7% difference (95% CI, −10.6 to +20.9).LimitationsTertiary referral centers.ConclusionsThe results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm2 focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.