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用于消融非发育异常性巴雷特食管的球囊电极:肠化生的消融(AIM II试验)

Balloon-based electrode for the ablation of non-dysplastic Barrett's esophagus: ablation of intestinal metaplasia (AIM II Trial).

作者信息

Avilés Amarilis, Reymunde Alvaro, Santiago Nilda

机构信息

Ponce Gastroenterology Center & Internal Medicine Residency, Damas Hospital - Ponce School of Medicine Teaching Consortium, Ponce, Puerto Rico.

出版信息

Bol Asoc Med P R. 2006 Oct-Dec;98(4):270-5.

PMID:19610568
Abstract

INTRODUCTION

Barrett's esophagus (BE) is a condition in which an abnormal intestinal-type epithelium called specialized intestinal metaplasia (SIM) replaces the stratified squamous epithelium that normally lines the distal esophagus. This occurs as a consequence of chronic gastroesophageal reflux disease (GERD) which is present in more than 20% of adults. It is present in 1-2% of the United States population with an estimated prevalence as high as 25% in white males older than 50 yrs without GERD. This intestinal metaplasia predisposes patients to esophageal adenocarcinoma, the most rapidly rising tumor incidence over the last 30 years, with an annual incidence of 0.5% in patients with BE and a survival rate less than 10% in 5 years. The objective of the study was to assess the safety and efficacy of circumferential endoscopic ablation of Barrett's esophagus using the HALO360 System.

METHODS

Patients with non-dysplastic Barrett's esophagus confirmed within the previous year were treated twice per session with a balloon-based, bipolar radiofrequency ablation device with a pre selected energy of 10 J/ cm2 at 260 W for 10 secs, achieving full thickness ablation of epithelium followed by Omeprazole 40 mg PO BID for 1 month and then, daily. Patients were followed at 1, 3, 6 and 12 months with EGD with biopsy and a 2nd re treatment at 4 month if IM persisted.

RESULTS

A total of 21 Hispanic patients underwent treatment with a gender distribution of 9 female and 10 male, at a mean age of 59.6 years old (SD +/- 12.9) and a mean weight of 161 Lbs (SD +/- 26.1). There was a complete response of 66.7%, 61.9%, 76.2%, 76.2% at 1, 3, 6, and 12 month respectively and a biopsy clearance rate (BCR) of 84.6% and 92.3% at 6 and 12 mo with single treatment and of 62.5% and 50.0% at 6 and 12 month in retreated patients. No complications from the procedure such as strictures or ulcers were reported at 1 year after treatment.

CONCLUSIONS

In spite of the multiple treatment options for BE, especially among ablation techniques, radiofrequency ablation therapy is achieving promising results with a full thickness ablation of Barrett's epithelium in 76.2% of patients without direct injury to the submucosa, avoiding formation of strictures and minimal side effects from treatment.

摘要

引言

巴雷特食管(BE)是一种异常肠化生(SIM)取代远端食管正常复层鳞状上皮的病症。这是慢性胃食管反流病(GERD)导致的结果,超过20%的成年人患有此病。在美国人群中,其发病率为1%-2%,据估计,在50岁以上无GERD的白人男性中,患病率高达25%。这种肠化生使患者易患食管腺癌,这是过去30年中发病率上升最快的肿瘤,BE患者的年发病率为0.5%,5年生存率低于10%。本研究的目的是评估使用HALO360系统对巴雷特食管进行环形内镜消融的安全性和有效性。

方法

对前一年确诊的非发育异常性巴雷特食管患者,每次使用基于球囊的双极射频消融设备进行两次治疗,预先选定能量为10J/cm²,功率260W,持续10秒,实现上皮全层消融,随后口服奥美拉唑40mg,每日两次,持续1个月,之后改为每日一次。患者在1、3、6和12个月时接受内镜下食管胃十二指肠镜检查(EGD)及活检随访,若肠化生持续存在,则在4个月时进行第二次再治疗。

结果

共有21名西班牙裔患者接受治疗,性别分布为9名女性和10名男性,平均年龄59.6岁(标准差±12.9),平均体重161磅(标准差±26.1)。在1、3、6和12个月时的完全缓解率分别为66.7%、61.9%、76.2%、76.2%,在6个月和12个月时,单次治疗的活检清除率(BCR)分别为84.6%和92.3%,再次治疗患者在6个月和12个月时的活检清除率分别为62.5%和50.0%。治疗后1年未报告手术相关并发症,如狭窄或溃疡。

结论

尽管巴雷特食管有多种治疗选择,尤其是在消融技术方面,但射频消融治疗取得了令人鼓舞的结果,76.2%的患者实现了巴雷特上皮全层消融,且未直接损伤黏膜下层,避免了狭窄形成,治疗副作用最小。

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