Mayo Clinic, 13400 East Shea Boulevard, Scottsdale, AZ 85259, USA.
Endoscopy. 2010 Oct;42(10):781-9. doi: 10.1055/s-0030-1255779. Epub 2010 Sep 20.
The AIM-II Trial included patients with nondysplastic Barrett's esophagus (NDBE) treated with radiofrequency ablation (RFA). Complete eradication of NDBE (complete response-intestinal metaplasia [CR-IM]) was achieved in 98.4 % of patients at 2.5 years. We report the proportion of patients demonstrating CR-IM at 5-year follow-up.
Prospective, multicenter US trial (NCT00489268). After endoscopic RFA of NDBE up to 6 cm, patients with CR-IM at 2.5 years were eligible for longer-term follow-up. At 5 years, we obtained four-quadrant biopsies from every 1 cm of the original extent of Barrett's esophagus. All specimens were reviewed by one expert gastrointestinal pathologist, followed by focal RFA and repeat biopsy if NDBE was identified. Primary outcomes were (i) proportion of patients demonstrating CR-IM at 5-year biopsy, and (ii) proportion of patients demonstrating CR-IM at 5-year biopsy or after the single-session focal RFA.
Of 60 eligible patients, 50 consented to participate. Of 1473 esophageal specimens obtained at 5 years 85 % contained lamina propria or deeper tissue (per patient, mean 30 , standard deviation [SD] 13). CR-IM was demonstrated in 92 % (46 / 50) of patients, while 8 % (4 / 50) had focal NDBE; focal RFA converted all these to CR-IM. There were no buried glands, dysplasia, strictures, or serious adverse events. Kaplan-Meier CR-IM survival analysis showed probability of maintaining CR-IM for at least 4 years after first durable CR-IM was 0.91 (95 % confidence interval [CI] 0.77 - 0.97) and mean duration of CR-IM was 4.22 years (standard error [SE] 0.12).
In patients with NDBE treated with RFA, CR-IM was demonstrated in the majority of patients (92 %) at 5-year follow-up, biopsy depth was adequate to detect recurrence, and all failures (4 / 4, 100 %) were converted to CR-IM with single-session focal RFA.
AIM-II 试验纳入了接受射频消融 (RFA) 治疗的非异型性 Barrett 食管 (NDBE) 患者。98.4%的患者在 2.5 年内达到 NDBE 的完全根除（完全应答-肠化生 [CR-IM]）。我们报告了在 5 年随访时达到 CR-IM 的患者比例。
前瞻性、多中心美国试验（NCT00489268）。在对 NDBE 进行内镜下 RFA 治疗后，达到 2.5 年 CR-IM 的患者有资格接受更长期的随访。在 5 年时，我们从 Barrett 食管的原始范围的每 1cm 处获得四个象限的活检。所有标本均由一位专家胃肠病理学家进行评估，如果发现 NDBE，则进行焦点 RFA 和重复活检。主要结局是（i）5 年活检时达到 CR-IM 的患者比例，以及（ii）5 年活检或单次焦点 RFA后达到 CR-IM 的患者比例。
在 60 名符合条件的患者中，有 50 名同意参加。在 5 年时获得的 1473 个食管标本中，85%（每例患者，平均 30 个，标准差 [SD] 13）含有固有层或更深组织。92%（46/50）的患者表现出 CR-IM，8%（4/50）有局灶性 NDBE；局灶性 RFA 将所有这些转化为 CR-IM。没有发现埋藏的腺体、发育不良、狭窄或严重不良事件。Kaplan-Meier CR-IM 生存分析显示，首次持久 CR-IM 后至少维持 4 年 CR-IM 的概率为 0.91（95%置信区间 [CI] 0.77-0.97），CR-IM 的平均持续时间为 4.22 年（标准误差 [SE] 0.12）。
在接受 RFA 治疗的 NDBE 患者中，在 5 年随访时，大多数患者（92%）表现出 CR-IM，活检深度足以检测复发，所有失败（4/4，100%）均通过单次焦点 RFA 转化为 CR-IM。
