Circumferential cryoablation in a strictured esophagus: a feasibility and dose-finding study in a porcine model after...

In the treatment of early esophageal Barrett's neoplasia, radiofrequency ablation may be hindered by stenosis due to prior endoscopic resection (ER). The flexible balloon-based circumferential CryoBalloon Ablation System (CBAS) may overcome this problem by the conformability of the compliant balloon which might enable circumferential cryoablation in a stenosis. The aim of the current study was to evaluate the feasibility of the CBAS as well as the dose-response effect of cryoablation in a strictured esophagus model. In six pigs, a stenosis was induced by ER (3 cm in length, 75% of circumference) in the proximal, mid, and distal esophagus. After 28 days, cryoablation with the CBAS was performed, with the length of ablation time (6, 8, or 10 seconds) randomly assigned per stricture location within the esophagus. Four days post-ablation, the esophagi were harvested for histopathological assessment of the percentage of the total circumference affected by cryoablation and the maximum depth of necrosis. At 28 days, all 18 ER areas had transformed into strictures with ±50% of its original diameter remaining. In 9 of 18 strictures, more than one attempt for cryoablation was necessary due to displacement of the balloon. Histopathological evaluation showed a wide range in circumferential uniformity (0-100%) and maximum necrosis depth (epithelium to external proper muscle layer) of cryoablation, both independent of ablation times. Deepest ablation effects were seen at the center of the resection-induced scar. This first generation CryoBalloon Focal Ablation System was not feasible for ablation within severe stenoses, since it results in inconsistent circumferential uniformity of cryoablation with subsequent differences in depth of ablation. Further research with a next generation CBAS in a more realistic stricture model is warranted.