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

Abstract

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.

Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus (with video)

“…1E and G). All patients underwent at least 1 cryoablation procedure (range, [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. The total number of cryoablation procedures for the intention-to-treat cohort was 117, with a technical success rate of 115 of 117 (98%) because of 2 incomplete cryoablation treatments (2 patients) related to balloon migration from a pre-existing stricture.…”

“…A prior human dosing trial demonstrated 100% ablation of IM in a focal area treated with 10 seconds of cryogen. 12 Similarly, a recent 30 patient clinical trial showed that 10 seconds of ice applied with the focal cryoballoon device was successful in targeting dysplastic BE islands in 94% and associated with 100% CE of BE treated. 13 Procedure times for cryoballoon ablation are short, averaging 30 minutes.…”

“…The initial application of CbFAS for focal ablation of BE was a multicenter international dose-finding trial, which showed full squamous regeneration in all 10-second treated areas. 12 A recent prospective clinical trial (n Z 30) confirmed complete eradication of flat dysplastic BE islands. 13 Therefore, we performed a clinical trial to assess the feasibility of cryoballoon ablation using the CbFAS for CE-D and CE-IM in neoplastic BE.…”

“…Endoscopic cryoballoon ablation was performed at a separate visit using the focal CbFAS with a cryogen dose of 10 seconds based on the results of a human doseescalation trial, which demonstrated that 10 seconds of ice led the highest ablation response without significant adverse effects. 12 Prior animal dosing experiments using squamous-lined porcine esophagus showed varying degrees of submucosal edema and inflammation and patchy edema, inflammation, and injury but not necrosis in the muscularis propria with a 10-second cryoablation. 11 The 3.7-mm focal cryoballoon catheter was passed through a standard or high-definition therapeutic channel videoendoscope or placed through an accessory "side car" (Fig.…”

Barrett's esophagus: diagnosis and management

“…A newer device is also available to deliver cryotherapy using nitrous oxide via a self-contained, balloon based system [127]. Cryoablation can achieve complete eradication of HGD in a high proportion of patients with BE in retrospective studies, with good durability during a 24-month follow-up period [128, 129].…”