Background and Aims

Endoscopic cryotherapy can eradicate neoplastic Barrett’s esophagus (BE). A new contact cryoballoon focal ablation system (CbFAS)) freezes esophageal mucosa with nitrous oxide. We studied the safety and efficacy of CbFAS for complete eradication of neoplastic Barrett's esophagus.

Methods

In a prospective clinical trial, consecutive BE patients with confirmed neoplasia (low-grade dysplasia LGD, high-grade dysplasia HGD, and/or intramucosal adenocarcinoma ImCA), at least 1 cm of BE, with or without prior ablation, were treated with a dose 10 seconds of spray per site. EMR was performed for nodular lesions. Treatments were repeated every 10 to 12 weeks until complete eradication, with a maximum of 5. Primary outcomes were complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year (intention-to-treat analysis).

Results

Forty-one evaluable patients (22 treatment-naïve, 19 previously ablated) with LGD (n=13), HGD (n=23) or ImCA (n=5) were treated. The median procedure time was 30 minutes. The median number of ablation procedures for CE-IM was 3 (IQ range 2-4). Overall 1-year CE-D and CE-IM rates were 95% and 88%, respectively. CE-D rate was significantly lower (67%) in those with ultra-long BE compared with those with <8 cm (100%, p=0.02). Median pain scores were zero at day 1. Four patients (9.7%) developed mild dysphagia from stenoses requiring dilation. One patient on aspirin developed upper GI bleeding, not requiring therapy.

Conclusion

Multifocal nitrous oxide cryotherapy using CbFAS is a promising, highly effective, and safe endoscopic treatment for primary or rescue therapy of BE-associated neoplasia and intestinal metaplasia. (ClinicalTrials.gov number NCT02534233)

中文翻译：

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多灶一氧化二氮冷冻球囊切除术伴或不伴EMR治疗肿瘤Barrett食管

背景和目标

内窥镜冷冻疗法可以根除肿瘤的Barrett食道（BE）。一种新的接触式冷冻球囊局部消融系统（CbFAS）用一氧化二氮冷冻食管粘膜。我们研究了CbFAS完全根除肿瘤性Barrett食道的安全性和有效性。

方法

在一项前瞻性临床试验中，对连续确诊为瘤样病变（低度增生LGD，高度增生性HGD和/或粘膜内腺癌ImCA的BE患者），BE至少1 cm且有或无事先消融的患者进行了治疗。每个部位喷洒10秒钟喷雾剂。对结节性病变进行EMR。每10到12周重复治疗，直至完全根除，最多5次。主要结果是在1年时完全根除所有异型增生（CE-D）和肠化生（CE-IM）（意向性治疗分析） 。

结果

接受LGD（n = 13），HGD（n = 23）或ImCA（n = 5）治疗的41例可评估患者（未治疗22例，之前消融的19例）。中位手术时间为30分钟。CE-IM的消融手术中位数为3（IQ范围为2-4）。总体1年CE-D和CE-IM比率分别为95％和88％。与＜8 cm的患者相比，超长BE的患者的CE-D率显着降低（67％）（100％，p = 0.02）。第1天的中位疼痛评分为零。四名患者（9.7％）因需要扩张的狭窄而出现轻度吞咽困难。一名接受阿司匹林治疗的患者出现了上消化道出血，无需治疗。

结论

使用CbFAS的多焦点一氧化二氮冷冻疗法是一种有前途，高效且安全的内窥镜治疗，可用于BE相关肿瘤和肠上皮化生的原发或抢救治疗。（ClinicalTrials.gov编号NCT02534233）