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

Background The 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. Objective To compare the efficacy of 2 focal RFA regimens. Setting Three tertiary referral centers. Patients Consecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled. Interventions BE areas were paired: 1 area was randomized to the "standard" regimen (2 × 15 J/cm 2 –clean–2 × 15 J/cm 2 ) or to the "simplified" regimen (3 × 15 J/cm 2 –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 Measure Proportion 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 Results Forty-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). Limitations Tertiary referral centers. Conclusions The results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm 2 focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.