Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study
Treatment of Barrett's esophagus with a novel focal cryoablation device: a safety and feasibility study
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DOI：
10.1055/s-0034-1392417
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发表时间：
2015-12-01
期刊：
影响因子：
9.3
通讯作者：
Weusten, Bas L. A. M.
中科院分区：
文献类型：
--
作者：
Scholvinck, Dirk W.;Kunzli, Hannah T.;Weusten, Bas L. A. M.
背景和目标：目前，巴雷特上皮的根除优选使用射频消融（RFA）或喷雾冷冻消融（SCA）来实现。然而，这两种模式都有缺点，例如需要定尺寸、多个部署步骤、大的控制器单元（RFA）、不精确的剂量和需要排气（SCA）。新的冷冻球囊局灶性消融系统（CbFAS）可以解决这些局限性。本研究评估的安全性，可行性和剂量反应的CbFAS患者与平坦的Barrett上皮细胞或无dysplasia.Patients和方法：在这个多中心，前瞻性非随机试验，39例患者分别治疗一个或两个消融6，8，或10秒。冷冻消融后立即和2天评估症状。术后6-8周进行随访内镜检查，以评估反应。结果参数是不良事件的发生率，疼痛，食管狭窄的形成，和消融反应的冷冻剂dose.Results：62消融，56（10与6秒，28与8秒，18与10秒）成功进行。6次消融因器械故障（n = 3）和手术或解剖问题（n = 3）而失败。中位手术时间为7分钟（四分位距[IQR] 4-10）。未发生重大不良事件; 6例患者发生轻微粘膜撕裂，无需干预。27%的患者在冷冻消融术后立即报告轻度疼痛，14%的患者在2天后报告轻度疼痛。随访时无明显狭窄。在47个治疗区域中观察到完全鳞状再生（6秒区域中的6个[60%]; 8秒区域中的23个[82%]; 10秒区域中的18个[100%]）。结论：使用CbFAS对Barrett上皮进行局灶性冷冻消融是可行且安全的，导致大多数患者的鳞状再生。
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.