Background and Aims

Radiofrequency ablation (RFA) is safe and effective for eradicating Barrett’s esophagus (BE) but is associated with significant postprocedural pain. Alternatively, balloon-based focal cryoablation (CRYO) has recently been developed, which preserves the extracellular matrix and might therefore be less painful. Although data for CRYO are still limited, uncontrolled studies suggest comparable safety and efficacy to RFA in eradicating limited BE areas. Therefore, secondary endpoints such as pain might become decisive for treatment selection. We aimed to compare efficacy and tolerability between focal CRYO and RFA.

Methods

We identified BE patients undergoing focal ablation (either RFA or CRYO) of all visible BE from our prospective cohort in 2 Dutch referral centers. After ablation, patients completed a 14-day digital diary to assess chest pain (0-10), dysphagia (0-4), and analgesics use. A follow-up endoscopy was scheduled after 3 months to assess the BE surface regression (blindly scored by 2 independent BE expert endoscopists). Outcomes were BE surface regression; 14-day cumulative scores (area under the curves [AUCs]) for pain, dysphagia, analgesics, and peak pain.

Results

We identified 46 patients (20 CRYO, 26 RFA) with similar baseline characteristics. The BE regression was comparable (88% vs 90%, P = .62). AUCs for pain, dysphagia, and analgesics were significantly smaller after CRYO versus RFA (all P < .01). Peak pain was lower after CRYO (visual analog scale 2 vs 4, P < .01), and the duration of pain was also shorter after CRYO (2 vs 4 days, P < .01). CRYO patients used analgesics for 2 days versus 4 days for RFA (P < .01).

Conclusions

In this multicenter, nonrandomized cohort study, we found no differences in efficacy after a single treatment with CRYO and RFA for short-segment BE. Patients reported less pain after CRYO as compared with RFA. Moreover, CRYO patients used fewer analgesics. Our results suggest a different pain course favoring CRYO over RFA, but a randomized trial is needed for definitive conclusions. (Clinical trial registration number: NCT02249975.)

中文翻译：

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局灶性冷冻气球与不典型增生的巴雷特食管的射频消融：对治疗反应和术后疼痛的影响

背景和目标

射频消融（RFA）可以安全有效地根除Barrett食道（BE），但会引起严重的术后疼痛。可替代地，最近已经开发了基于气球的局灶性冷冻消融术（CRYO），其保留了细胞外基质，因此可能减轻了痛苦。尽管CRYO的数据仍然有限，但未经控制的研究表明，在消除有限的BE区域方面，安全性和有效性与RFA相当。因此，次要终点（例如疼痛）可能对选择治疗起决定性作用。我们旨在比较CRYO和RFA的疗效和耐受性。

方法

我们从两个荷兰转诊中心的前瞻性队列中确定了所有可见BE的接受局部消融（RFA或CRYO）的BE患者。消融后，患者完成了为期14天的数字日记，以评估胸痛（0-10），吞咽困难（0-4）和止痛药的使用。3个月后安排随访内窥镜检查以评估BE表面消退（由2名独立的BE专家内镜医师盲目评分）。结果是BE表面消退；疼痛，吞咽困难，止痛药和峰值疼痛的14天累积评分（曲线下的面积[AUCs]）。

结果

我们确定了46例患者（20例CRYO，26例RFA）具有相似的基线特征。BE回归具有可比性（88％vs 90％，P = 0.62）。CRYO后与RFA相比，用于疼痛，吞咽困难和止痛药的AUC显着较小（所有P  <.01）。CRYO后的峰值疼痛较低（视觉模拟量表2 vs 4，P  <.01），CRYO后的疼痛持续时间也较短（2 vs 4天，P  <.01）。CRYO患者使用镇痛药的时间为2天，而RFA为4天（P  <.01）。

结论

在这项多中心，非随机队列研究中，我们发现CRYO和RFA单一治疗短节段BE后的疗效无差异。与RFA相比，患者报告CRYO后的疼痛更少。此外，CRYO患者使用的镇痛药较少。我们的结果表明，与RFA相比，CRYO优于CRYO，但需要进行随机试验才能得出明确的结论。（临床试验注册号：NCT02249975。）