Background and Aims

Focal cryoballoon ablation (FCBA) is currently being investigated for the treatment of Barrett’s esophagus (BE)-related neoplasia in a European multicenter study (Euro-Coldplay study). After inclusion of 28 of 107 patients, the initial dose of 10 seconds was lowered to 8 seconds. The current study aimed to compare the efficacy and safety of a single FCBA treatment session with 10 seconds versus 8 seconds.

Methods

Treatments were performed at 7 European BE referral centers. All 28 patients treated with 10 seconds were compared with 28 consecutive patients treated with 8 seconds. The gastroesophageal junction was ablated circumferentially followed by all visible BE. To assess efficacy and safety, 3 expert adjudicators, blinded to physician and dose, compared pre- and post-treatment images. Primary outcomes were median BE surface regression and stricture rate after single-session FCBA.

Results

We included 56 patients (10-second cohort, n = 28; 8-second cohort, n = 28) with a median BE length of C0M2 (Prague classification). Baseline characteristics did not significantly differ between the cohorts. The median BE surface regression after a single FCBA session was comparable for 10 seconds and 8 seconds (80% [95% confidence interval {CI}, 75-90] and 80% [95% CI, 66-90], respectively; P = .65). Strictures requiring dilation were seen in 19% (95% CI, 4-33) and 15% (95% CI, 4-30) of the 10-second and 8-second groups, respectively (P = 1.00). Two patients in the 10-second group developed a severe stricture requiring >3 dilations.

Conclusions

In patients with limited BE, single-session FCBA with 8 seconds showed similar BE surface regression as compared with 10 seconds and may theoretically result in fewer and less severe strictures. Therefore, we suggest using 8 seconds as the standard dose for FCBA. (Clinical trial registration number: NL7253.)

中文翻译：

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局灶性冷冻球囊消融与 10 秒和 8 秒剂量治疗巴雷特食管相关肿瘤的比较：来自一项前瞻性欧洲多中心研究的结果（附视频）

背景和目标

欧洲多中心研究（Euro-Coldplay 研究）目前正在研究局灶性冷冻球囊消融术 (FCBA) 用于治疗巴雷特食管 (BE) 相关瘤形成。在纳入 107 名患者中的 28 名后，10 秒的初始剂量降低到 8 秒。目前的研究旨在比较 10 秒与 8 秒单次 FCBA 治疗的有效性和安全性。

方法

治疗在 7 个欧洲 BE 转诊中心进行。将所有 28 名接受 10 秒治疗的患者与连续 28 名接受 8 秒治疗的患者进行比较。胃食管交界处周向消融，然后是所有可见的 BE。为了评估疗效和安全性，3 位专家评审员（不知道医生和剂量）比较了治疗前和治疗后的图像。主要结果是单次 FCBA 后的中位 BE 表面回归和狭窄率。

结果

我们纳入了 56 名患者（10 秒队列，n = 28；8 秒队列，n = 28），中位 BE 长度为 C0M2（布拉格分类）。队列之间的基线特征没有显着差异。单次 FCBA 会话后的中值 BE 表面回归在 10 秒和 8 秒内具有可比性（分别为 80% [95% 置信区间 {CI}，75-90] 和 80% [95% CI，66-90]；P  = .65)。在 10 秒组和 8 秒组中，分别有 19% (95% CI, 4-33) 和 15% (95% CI, 4-30) 出现需要扩张的狭窄 ( P  = 1.00)。10 秒组中的两名患者出现严重狭窄，需要 >3 次扩张。

结论

在 BE 受限的患者中，8 秒的单次 FCBA 与 10 秒的 BE 表面回归相似，理论上可能导致越来越少的严重狭窄。因此，我们建议使用 8 秒作为 FCBA 的标准剂量。（临床试验注册号：NL7253。）