Treatment of Barrett’s esophagus with a novel focal cryoablation device: a safety and feasibility study

Background and aims: Currently, eradication of Barrett’s epithelium is preferably achieved using radiofrequency ablation (RFA) or spray cryoablation (SCA). However, both modalities suffer from drawbacks such as the need for sizing, multiple deployment steps, large controller units (RFA), imprecise dosing and need for gas-venting (SCA). The new Cryoballoon Focal Ablation System (CbFAS) may address these limitations. This study assessed the safety, feasibility, and dose response of the CbFAS in patients with flat Barrett’s epithelium with or without dysplasia.

Patients and methods: In this multicenter, prospective non-randomized trial, 39 patients were each treated with one or two ablations of 6, 8, or 10 seconds. Symptoms were assessed immediately and 2 days post-cryoablation. Follow-up endoscopy was performed 6 – 8 weeks post-procedure to assess response. Outcome parameters were incidence of adverse events, pain, esophageal stricture formation, and ablation response by cryogen dose.

Results: Of 62 ablations, 56 (10 with 6 seconds, 28 with 8 seconds, 18 with 10 seconds) were successfully performed. Six ablations failed because of device malfunction (n = 3) and procedural or anatomic issues (n = 3). Median procedure time was 7 minutes (interquartile range [IQR] 4 – 10). No major adverse events occurred; six patients experienced a minor mucosal laceration requiring no intervention. Mild pain was reported by 27 % of patients immediately after cryoablation and by 14 % after 2 days. No strictures were evident at follow-up. Full squamous regeneration was seen in 47 treated areas (6 [60 %] of the 6-second areas; 23 [82 %] of the 8-second areas; 18 [100 %] of 10-second areas).

Conclusions: Focal cryoablation of Barrett’s epithelium with the CbFAS is feasible and safe, resulting in squamous regeneration in the majority of patients.

• References

• 1 Shaheen NJ, Richter JE. Barrett’s oesophagus. Lancet 2009; 373: 850-861
• 2 American Gastroenterological Association. Spechler SJ, Sharma P et al. American Gastroenterological Association medical position statement on the management of Barrett’s esophagus. Gastroenterology 2011; 140: 1084-1091
• 3 May A, Gossner L, Pech O et al. Local endoscopic therapy for intraepithelial high-grade neoplasia and early adenocarcinoma in Barrett’s oesophagus: acute-phase and intermediate results of a new treatment approach. Eur J Gastroenterol Hepatol 2002; 14: 1085-1091
• 4 Shaheen NJ, Sharma P, Overholt BF et al. Radiofrequency ablation in Barrett’s esophagus with dysplasia. NEJM 2009; 360: 2277-2288
• 5 Pouw RE, Wirths K, Eisendrath P et al. Efficacy of radiofrequency ablation combined with endoscopic resection for Barrett’s esophagus with early neoplasia. Clin Gastroenterol Hepatol 2010; 8: 23-29
• 6 Ganz RA, Utley DS, Stern RA et al. Complete ablation of esophageal epithelium with a balloon-based bipolar electrode: a phased evaluation in the porcine and in the human esophagus. Gastrointest Endosc 2004; 60: 1002-1010
• 7 Dunkin BJ, Martinez J, Bejarano PA et al. Thin-layer ablation of human esophageal epithelium using a bipolar radiofrequency balloon device. Surg Endosc 2006; 20: 125-130
• 8 Greenwald BD, Dumot JA, Abrams JA et al. Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy. Gastrointest Endosc 2010; 71: 686-693
• 9 Shaheen NJ, Greenwald BD, Peery AF et al. Safety and efficacy of endoscopic spray cryotherapy for Barrett’s esophagus with high-grade dysplasia. Gastrointest Endosc 2010; 71: 680-685
• 10 Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology 1998; 37: 171-186
• 11 Evonich 3rd RF, Nori DM, Haines DE. A randomized trial comparing effects of radiofrequency and cryoablation on the structural integrity of esophageal tissue. J Interv Cardiac Electrophysiol 2007; 19: 77-83
• 12 DeMeester SR, Awais O, Bergman JJ et al. Initial human experience with a novel through-the-scope cryoballoon device for mucosal ablation. Gastroenterology 2012; 142 Suppl 1: S1038
• 13 Endoscopic Classification Review Group. Update on the Paris classification of superficial neoplastic lesions in the digestive tract. Endoscopy 2005; 37: 570-578
• 14 Gosain S, Mercer K, Twaddell WS et al. Liquid nitrogen spray cryotherapy in Barrett’s esophagus with high-grade dysplasia: long-term results. Gastrointest Endosc 2013; 78: 260-265
• 15 Overholt BF, Lightdale CJ, Wang KK et al. Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett’s esophagus: international, partially blinded, randomized phase III trial. Gastrointest Endosc 2005; 62: 488-498
• 16 Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc 2011; 74: 182-188
• 17 Verbeek RE, Vleggaar FP, Ten Kate FJ et al. Cryospray ablation using pressurized carbon dioxide gas for the ablation of Barrett’s esophagus with early neoplasia. Gastrointest Endosc 2012; 75: AB453
• 18 Shaheen NJ, Frantz DJ. When to consider endoscopic ablation therapy for Barrett’s esophagus. Curr Opin Gastroenterol 2010; 26: 361-366
• 19 Johnston MH, Eastone JA, Horwhat JD et al. Cryoablation of Barrett’s esophagus: a pilot study. Gastrointest Endosc 2005; 62: 842-848
• 20 Erinjeri JP, Clark TW. Cryoablation: mechanism of action and devices. J Vasc Interv Radiol 2010; 21: 187-191
• 21 Greenwald BD, Dumot JA, Horwhat JD et al. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus 2010; 23: 13-19