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.
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Abbreviations
- BE:
-
Barrett’s esophagus
- CbFAS:
-
Cryoballoon focal ablation system
- EMR:
-
Endoscopic mucosal resection
- IQR:
-
Interquartile range
- MBM:
-
Multi-band mucosectomy
- RFA:
-
Radiofrequency ablation
- SD:
-
Standard deviation
- UES:
-
Upper esophageal sphincter
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Acknowledgments
The authors thank Koen Vaessen, Nico Attevelt, and Hester de Bruin for their biotechnical assistance, Pentax Medical of America, for providing all materials required for CbFAS treatment free of charge and Olympus Nederland for providing endoscopy materials required for performing the endoscopic resections and placing an endoscopy trolley at the animal laboratory for the duration of the study free of charge.
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All authors were involved in conception and design of the study. AO and BW were involved in analyses, interpretation of the data, and drafting of the manuscript. All authors were involved in critical revision for intellectual content. All authors were involved in final approval of the manuscript.
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B.L.A.M. Weusten received financial support for IRB-approved studies from Pentax Medical. A. Overwater, L.A.A. Brosens, and G.J.A. Offerhaus have no conflicts of interest or financial ties to disclose.
Ethical statements
This study was approved by the Animal Welfare Body Utrecht after overall project approval by the Animal Experiment Committee. The study was conducted in accordance with the Experiments on Animals Act. All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. All procedures performed were in accordance with the ethical standards of the institution at which the studies were conducted. The manuscript was written according to the ARRIVE guidelines on reporting of in vivo experiments in animals [17].
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This study was presented as an ePoster Podium presentation during the ESGE Days on April 6, 2019, in Prague.
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Video of both single-step treatment regimens (MP4 127491 kb)
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Overwater, A., Brosens, L.A.A., Offerhaus, G.J.A. et al. Single-Step Treatment with Limited Endoscopic Resection and Cryoballoon Ablation Is Feasible and Safe in an Esophageal Porcine Model. Dig Dis Sci 65, 3175–3183 (2020). https://doi.org/10.1007/s10620-020-06054-3
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DOI: https://doi.org/10.1007/s10620-020-06054-3