Single-Step Treatment with Limited Endoscopic Resection and Cryoballoon Ablation Is Feasible and Safe in an Esophageal Porcine Model

Abstract

Background: Treatment of Barrett’s neoplasia consists of two steps: endoscopic resection of visible lesions with subsequent ablation of remaining Barrett’s epithelium. However, extensive resection might hamper subsequent ablation due to stenosis. Combining both modalities in one session therefore offers potential advantages. Single-step treatment with radiofrequency ablation and resection appeared to be unsafe. Aims: To evaluate feasibility and safety of single-step treatment with cryoballoon ablation and endoscopic resection. Methods: Two single-step treatment regimens (15 treatment areas per regimen) were evaluated: (1) CRYO-EMR: four side-by-side focal ablations of 10 seconds followed by resection in the treated area; (2) EMR-CRYO: resection followed by 10-s ablation targeted on the resection wound. Primary outcome for both regimens was safety (perforations, clinically relevant strictures) and for CRYO-EMR also feasibility of resection and histopathological evaluation. Secondly, all CRYO-EMR and esophageal resection specimens were histopathologically evaluated. Results: Six female pigs were treated (five treatment areas per animal). During 28 days of follow-up, no perforations or clinically relevant stenosis occurred. All resections were technically successful. For all CRYO-EMR specimens, histopathological evaluation was feasible with ablation effects present throughout all layers, while the architecture requisite for histopathological analysis remained intact. After 28 days, histopathological evaluation of the esophagi was performed. For EMR-CRYO, post-treatment fibrosis was present throughout the submucosa. The muscularis propria was the deepest layer involved for CRYO-EMR. Conclusions: Single-step treatment with limited endoscopic resection and cryoballoon ablation is feasible and safe in a porcine model and justifies further evaluation in a clinical trial.