Simplified protocol for focal radiofrequency ablation using the HALO90 device: short-term efficacy and safety in patients with dysplastic Barrett's esophagus.

BACKGROUND AND STUDY AIMS: The standard protocol for focal radiofrequency ablation (RFA) of Barrett's esophagus comprises two applications of radiofrequency energy, cleaning of the ablated areas and catheter, and two further applications (2 × 15 J/cm(2) - cleaning - 2 × 15 J/cm(2)). A simplified protocol (3 × 15 J/cm(2), no cleaning) proved noninferior to standard protocol for individual islands of Barrett's esophagus, but may be associated with higher stenosis rates when applied circumferentially and sequentially over time. We evaluated the efficacy and safety of the above mentioned simplified protocol. PATIENTS AND METHODS: Barrett's esophagus patients undergoing focal RFA using the simplified protocol in four tertiary referral centers were retrospectively included. During each focal ablation, the gastroesophageal junction (GEJ) was ablated circumferentially in addition to Barrett's esophagus islands or tongues. Sessions continued at 8 to 12-week intervals until complete resolution of Barrett's esophagus. Primary outcome parameters comprised complete remission of dysplasia and of intestinal metaplasia, and stenosis requiring dilation.
RESULTS: 83 patients with dysplastic Barrett's esophagus (median Prague classification C1M3) were enrolled; 66/83 (80 %) had endoscopic resection of a visible lesion before RFA. Intention-to-treat analysis showed complete remission of dysplasia in 78/83 (94 %) and of intestinal metaplasia in 72/83 (87 %). Stenosis requiring dilation developed in 9/83 (11 %), necessitating a median 2 dilation sessions (range 1 - 9), with ≥ 8 sessions in three patients.
CONCLUSION: A treatment algorithm incorporating the simplified protocol of 3 × 15 J/cm(2), with no cleaning, for all focal RFA sessions, appears effective. The associated number and severity of stenoses, however, raises safety concerns. © Georg Thieme Verlag KG Stuttgart · New York.