Medline ® Abstract for Reference 25
of 'Barrett's esophagus: Treatment with radiofrequency ablation'
A simplified regimen for focal radiofrequency ablation of Barrett's mucosa: a randomized multicenter trial comparing two ablation regimens.
van Vilsteren FG, Phoa KN, Alvarez Herrero L, Pouw RE, Sondermeijer CM, Visser M, Ten Kate FJ, van Berge Henegouwen MI, Weusten BL, Schoon EJ, Bergman JJ
Gastrointest Endosc. 2013 Jul;78(1):30-8. Epub 2013 Mar 23.
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<20% difference in the paired proportions.
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.
Department of Gastroenterology, Academic Medical Center, Amsterdam, the Netherlands.