TY - JOUR
T1 - A simplified regimen for focal radiofrequency ablation of Barrett's mucosa
T2 - a randomized multicenter trial comparing two ablation regimens
AU - van Vilsteren, Frederike G I
AU - Phoa, K Nadine
AU - Alvarez Herrero, Lorenza
AU - Pouw, Roos E
AU - Sondermeijer, Carine M T
AU - Visser, Mike
AU - Ten Kate, Fiebo J W
AU - van Berge Henegouwen, Mark I
AU - Weusten, Bas L A M
AU - Schoon, Erik J
AU - Bergman, Jacques J G H M
N1 - Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
PY - 2013/7
Y1 - 2013/7
N2 - 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.
AB - 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.
KW - Aged
KW - Barrett Esophagus/pathology
KW - Catheter Ablation/instrumentation
KW - Catheters
KW - Education, Medical, Continuing
KW - Esophageal Neoplasms/prevention & control
KW - Esophagoscopy/methods
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Minimally Invasive Surgical Procedures/methods
KW - Mucous Membrane/pathology
KW - Netherlands
KW - Operative Time
KW - Patient Selection
KW - Precancerous Conditions/pathology
KW - Risk Assessment
KW - Tertiary Care Centers
KW - Time Factors
KW - Treatment Outcome
U2 - https://doi.org/10.1016/j.gie.2013.02.002
DO - https://doi.org/10.1016/j.gie.2013.02.002
M3 - Article
C2 - 23528655
SN - 0016-5107
VL - 78
SP - 30
EP - 38
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 1
ER -