Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up
Endoscopic ablation of Barrett's esophagus: a multicenter study with 2.5-year follow-up
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DOI：
10.1016/j.gie.2008.03.008
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发表时间：
2008-11-01
影响因子：
7.7
通讯作者：
Wang, Kenneth K.
中科院分区：
文献类型：
--
作者：
Fleischer, David E.;Overholt, Bergein F.;Wang, Kenneth K.
背景：对于巴雷特食管患者而言，由于患有发育不良疗法的风险升高已被用来消除。最近有了令人鼓舞的短期结果。 （BE）建议使用终身监测内窥镜检查和食管腺癌。各种内窥镜圆周射频消融已被用来鼓励短期结果。目标：提供更长的后续行动并评估逐步圆周消融的长期安全性和功效，并为Be.DeSign增加局灶性消融。潜在的，多中心临床试验（NCT00489268）。设置：2004年5月至2月之间的八个美国中心2007年。患者：七十名受试者，具有2至6厘米的BE和肠道化生的组织学证据（IM）。间接：如果有残留IM，则在基线时进行圆周消融，并在4个月重复进行。在1、3、6、12和30个月获得后续活检标本。标本由中央病理委员会审查。在为期12个月的组织学证据（在12个月活检（绝对指示））或内镜外观的组织学证据后进行了12个月的随访后进行局灶性消融。受试者接受了埃索美瑞唑的控制食管反流。介绍结果测量：完全没有IM患者从12个月和30个月获得的活检标本中完全缺乏，定义为完全缓解的IM（CR-IM）。在69名可用的患者中有48例（每规程[PP] 70％，有69％的治疗[ITT]）实现。在61名可用患者中有60例（98％，ITT 97％）中，有60例在其他局灶性消融治疗后30个月中获得了CR-IM。在12或30个月时，没有标准化的活检方案检测到的狭窄或掩埋的腺粘膜，并且没有严重的不良事件。限制：这是一项不受控制的临床试验，有2。5年的随访。结论：逐步旋转和焦点和焦点和焦点消融导致98％的患者在2。5年随访中完全消除了IM。 （Astrointest Endosc 2008; 68：867-76。）。
Background: For patients with Barrett's esophagus because of an elevated risk for developing dysplasia therapies have been used to eradicate BE. Recently with encouraging short-term results. (BE), life-long surveillance endoscopy is recommended and esophageal adenocarcinoma. Various endoscopic circumferential radiofrequency ablation has been used with encouraging short-term results.Objective: To provide longer follow-up and to assess the long-term safety and efficacy of step-wise circumferential ablation with the addition of focal ablation for BE.Design: Prospective, multicenter clinical trial (NCT00489268).Setting: Eight U.S. centers, between May 2004 and February 2007.Patients: Seventy subjects with 2 to 6 cm of BE and histologic evidence of intestinal metaplasia (IM).Interventions: circumferential ablation was performed at baseline and repeated at 4 months if there was residual IM. Follow-up biopsy specimens were obtained at 1, 3, 6, 12, and 30 months. Specimens were reviewed by a central pathology board. Focal ablation was performed after the 12-month follow-up for histological evidence of IM at the 12-month biopsy (absolute indication) or endoscopic appearance suggestive of columnar-lined esophagus (relative indication). Subjects received esomeprazole for control of esophageal reflux.Main outcome measurements: Complete absence of IM per patient from biopsy specimens obtained at 12 and 30 months, defined as complete remission-IM (CR-IM).Results: At 12 months, CR-IM was achieved in 48 of 69 available patients (70% per protocol [PP], 69% intention to treat [ITT]). At 30 months after additional focal ablative therapy, CR-IM was achieved in 60 of 61 available patients (98% PP, 97% ITT). There were no strictures or buried glandular mucosa detected by the standardized biopsy protocol at 12 or 30 months, and there were no serious adverse events.Limitations: This was an uncontrolled clinical trial with 2.5-year follow-up.Conclusion: Stepwise circumferential and focal ablation resulted in complete eradication of IM in 98% of patients at 2.5-year follow-up. (Gastrointest Endosc 2008;68:867-76.)