Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Division of Gastroenterology, University North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA.
Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5.
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.
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 treatments. Primary outcomes were complete eradication of all dysplasia (CE-D) and complete eradication of intestinal metaplasia (CE-IM) at 1 year (intention-to-treat analysis).
Forty-one assessable patients (22 treatment naive, 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 (interquartile 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 = .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 that did not require therapy.
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 IM. (Clinical trial registration number: NCT02534233.).
内镜下冷冻疗法可根除肿瘤性 Barrett 食管（BE）。一种新型接触式冷冻球囊聚焦消融系统（CbFAS）使用一氧化二氮冷冻食管黏膜。我们研究了 CbFAS 用于完全根除肿瘤性 Barrett 食管的安全性和有效性。
在一项前瞻性临床试验中，连续纳入至少 1 cm 长的伴有或不伴有先前消融的 BE 患者，这些患者的 BE 伴有明确的肿瘤性病变（低级别上皮内瘤变[LGD]、高级别上皮内瘤变[HGD]和/或黏膜内腺癌[ImCA]），采用 10 秒/点的喷雾剂量进行治疗。对于结节性病变，进行内镜黏膜下剥离术（EMR）。每隔 10 至 12 周重复治疗，直至完全根除，最多进行 5 次治疗。主要终点为 1 年时完全消除所有异型增生（CE-D）和完全消除肠化生（CE-IM）（意向治疗分析）。
41 例可评估患者（22 例初治，19 例先前消融）纳入研究，其中 LGD（n=13）、HGD（n=23）或 ImCA（n=5）患者接受治疗。中位手术时间为 30 分钟。CE-IM 的中位消融次数为 3 次（四分位距，2-4）。总体 1 年 CE-D 和 CE-IM 率分别为 95%和 88%。超长度 BE 的 CE-D 率显著低于<8 cm 的 BE（67% vs. 100%，P=0.02）。第 1 天的中位疼痛评分为 0 分。4 例（9.7%）患者因狭窄导致轻度吞咽困难，需要扩张治疗。1 例服用阿司匹林的患者出现上消化道出血，但无需治疗。
使用 CbFAS 的多部位一氧化二氮冷冻疗法是一种有前途的、高效且安全的内镜治疗方法，适用于 BE 相关肿瘤和 IM 的初次或挽救性治疗。（临床试验注册号：NCT02534233）。
