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A Multicenter Randomized Trial Comparing Two Ablation Regimens for Focal Radiofrequency Ablation of Barrett's Mucosa Using the HALO90 System
Frederike G. Van Vilsteren*1, Lorenza Alvarez Herrero2, Roos E. Pouw1, Kai Yi N. Phoa1, Carine Sondermeijer1, Mike Visser3, Fiebo J. Ten Kate3, Mark I. Van Berge Henegouwen4, Bas L. Weusten2, Erik J. Schoon5, Jacques J. Bergman1
1Gastroenterology, Academic Medical Center, Amsterdam, Netherlands; 2Gastroenterology, St Antonius Hospital, Nieuwegein, Netherlands; 3Pathology, Academic Medical Center, Amsterdam, Netherlands; 4Surgery, Academic Medical Center, Amsterdam, Netherlands; 5Gastroenterology, Catharina Ziekenhuis, Eindhoven, Netherlands
BACKGROUND: The currently recommended regimen for endoscopic focal radiofrequency ablation (RFA) of Barrett’s esophagus (BE) comprises two applications of energy, cleaning of the device and ablation zone, and two additional applications of energy. A simplified regimen may be of clinical utility, if it were faster, easier and equally safe and effective.
AIM: To compare the efficacy of two focal RFA regimens.
METHODS: In 3 centers, consecutive patients scheduled for endoscopic focal RFA of BE were enrolled having flat type BE with at least 2 BE islands or mosaic groups of islands (each less than the surface area of two HALO90 ablation catheters). Targeted BE areas were paired according to similar size: one of each area was randomized to the ’standard’ regimen (2x15J/cm2-clean-2x15J/cm2) or ’simplified’ regimen (3x15J/cm2-no clean), allocating the second area automatically to the other regimen. The % surface area of each target was scored at 2 months by the endoscopist, who was blinded to patient and regimen type. Patients underwent RFA every 2 months until complete histological response of each targeted BE area was achieved for neoplasia and intestinal metaplasia (CR-N; CR-IM). Primary outcome: CR-IM for each target at 2 months (non-inferiority defined as <20% difference in the paired proportions, sample size calculated at 46 pairs). Secondary outcome: surface regression (%) for each target at 2 months.
RESULTS: Forty-five equivalent pairs of target BE areas were randomized by Dec ’11, in 40 patients (29 male, age 64±12 years, BE C4M7). The proportion of targets showing CR-IM at 2 months after focal-RFA was 30/45 (66.7%) for standard and 33/45 (73.3%) for simplified: a difference of 6.7% (95%CI -12.2 to +25.6). The median surface regression for each target at 2 months was 100% in both groups, whereas for not completely eradicated areas this was 77.5% (IQR50-90)% for standard and 75% (IQR50-90) for simplified (p=1.0). No complications occurred. By Dec ’11, CR-IM and CR-N was achieved in 91.1% (31/34) and 100% of patients, whereas 7 patients are under treatment.
CONCLUSIONS:
The results of this multicenter randomized trial suggest that a simplified 3x15J/cm2 focal ablation regimen is not inferior to the standard regimen. Therefore, the simplified regimen may be recommended for residual Barrett’s islands.
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