Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus.
Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus.
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DOI：
10.1111/j.1442-2050.2009.00991.x
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发表时间：
2010-01
期刊：
影响因子：
--
通讯作者：
Abrams JA
中科院分区：
文献类型：
--
作者：
Greenwald BD;Dumot JA;Horwhat JD;Lightdale CJ;Abrams JA
内镜冷冻治疗是治疗食管不典型增生和肿瘤的新技术。初步研究表明它对这种适应症是安全有效的。本研究的目的是在多个研究地点的大型队列中表征低压液氮内镜喷雾冷冻治疗消融的安全性、耐受性和有效性。在美国四个三级保健学术医疗中心进行的平行前瞻性治疗研究评估了喷雾冷冻疗法对Barrett食管伴或不伴不典型增生、早期食管癌和严重鳞状不典型增生患者的治疗效果，这些患者接受了食道冷冻治疗消融。所有患者在治疗后1 - 10天接触，以评估治疗的副作用和并发症。主要结果测量是严重不良事件和治疗副作用的发生率。在研究期间完成治疗的患者中，评估了高级别发育不良（HGD） （CR-HGD）、所有发育不良（CR-D）、肠化生（CR-IM）和癌症（CR-C）的完全缓解。共有77例患者接受Barrett食管高级别不典型增生（58.4%）、粘膜内癌（16.9%）、浸润性癌（13%）、Barrett食管无不典型增生（9.1%）和重度鳞状不典型增生（2.6%）的治疗。22例（28.6%）患者在整个治疗过程中无副作用。在323例手术中，最常见的主诉是胸痛（17.6%），其次是吞咽困难（13.3%）、吞咽困难（12.1%）和喉咙痛（9.6%）。所有症状的平均持续时间为3.6天。48%的手术无副作用（155/323）。症状与年龄、性别、诊断或患者或部位经历的早期与晚期治疗无关。Logit分析显示，巴雷特氏节段长度为6厘米或更长者症状更严重。1例马凡氏综合征患者发生胃穿孔。3例出现食管狭窄，均经扩张治疗成功。在17例HGD患者中，冷冻治疗产生的CR-HGD、CR-D和CR-IM分别为94%、88%和53%。在所有7例粘膜内癌或I期食管癌患者中，肿瘤和HGD均完全消退。在食管内使用低压液氮的内镜下喷雾冷冻治疗是安全、耐受性良好和有效的。
Endoscopic cryotherapy is a new technique for ablation of esophageal dysplasia and neoplasia. Preliminary studies have shown it to be safe and effective for this indication. The objective of this study is to characterize safety, tolerability, and efficacy of low-pressure liquid nitrogen endoscopic spray cryotherapy ablation in a large cohort across multiple study sites. Parallel prospective treatment studies at four tertiary care academic medical centers in the U.S. assessed spray cryotherapy in patients with Barrett’s esophagus with or without dysplasia, early stage esophageal cancer, and severe squamous dysplasia who underwent cryotherapy ablation of the esophagus. All patients were contacted between 1 and 10 days after treatment to assess for side effects and complications of treatment. The main outcome measurement was the incidence of serious adverse events and side effects from treatment. Complete response for high-grade dysplasia (HGD) (CR-HGD), all dysplasia (CR-D), intestinal metaplasia (CR-IM) and cancer (CR-C) were assessed in patients completing therapy during the study period. A total of 77 patients were treated for Barrett’s high-grade dysplasia (58.4%), intramucosal carcinoma (16.9%), invasive carcinoma (13%), Barrett’s esophagus without dysplasia (9.1%), and severe squamous dysplasia (2.6%). Twenty-two patients (28.6%) reported no side effects throughout treatment. In 323 procedures, the most common complaint was chest pain (17.6%) followed by dysphagia (13.3%), odynophagia (12.1%), and sore throat (9.6%). The mean duration of any symptoms was 3.6 days. No side effects were reported in 48% of the procedures (155/323). Symptoms did not correlate with age, gender, diagnosis, or to treatment early versus late in the patient’s or site’s experience. Logit analysis showed that symptoms were greater in those with a Barrett’s segment of 6 cm or longer. Gastric perforation occurred in one patient with Marfan’s syndrome. Esophageal stricture developed in three, all successfully treated with dilation. In 17 HGD patients, cryotherapy produced CR-HGD, CR-D, and CR-IM of 94%, 88%, and 53%, respectively. Complete regression of cancer and HGD was seen in all seven patients with intramucosal carcinoma or stage I esophageal cancer. Endoscopic spray cryotherapy ablation using low-pressure liquid nitrogen in the esophagus is safe, well-tolerated, and efficacious.
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