Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands; Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, the Netherlands.
Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, the Netherlands; Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.
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.
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.
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).
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.).
射频消融（RFA）治疗 Barrett 食管（BE）安全有效，但与显著的术后疼痛相关。相反，基于球囊的局部冷冻消融（CRYO）最近得到了发展，它保留了细胞外基质，因此可能疼痛较轻。尽管 CRYO 的数据仍然有限，但对照研究表明，在消除有限的 BE 区域方面，其安全性和疗效与 RFA 相当。因此，次要终点（如疼痛）可能成为治疗选择的决定性因素。我们旨在比较局部 CRYO 和 RFA 的疗效和耐受性。
我们从荷兰 2 个转诊中心的前瞻性队列中确定了接受局部消融（RFA 或 CRYO）治疗的所有可见 BE 患者。消融后，患者在 14 天内完成数字日记，以评估胸痛（0-10）、吞咽困难（0-4）和镇痛药使用情况。3 个月后进行随访内镜检查，以评估 BE 表面消退情况（由 2 名独立的 BE 专家内镜医生盲法评分）。主要终点是 BE 表面消退；疼痛、吞咽困难、镇痛药和峰值疼痛的 14 天累积评分（曲线下面积[AUCs]）。
我们确定了 46 名患者（20 名 CRYO，26 名 RFA），基线特征相似。BE 消退情况相当（88%对 90%，P=0.62）。CRYO 组的疼痛、吞咽困难和镇痛药 AUC 均显著小于 RFA 组（均 P<0.01）。CRYO 组的峰值疼痛较低（视觉模拟量表 2 对 4，P<0.01），疼痛持续时间也较短（2 对 4 天，P<0.01）。CRYO 组患者使用镇痛药 2 天，而 RFA 组患者使用镇痛药 4 天（P<0.01）。
在这项多中心、非随机队列研究中，我们发现单次短节段 BE 治疗时，CRYO 和 RFA 的疗效无差异。与 RFA 相比，患者报告的 CRYO 后疼痛较轻。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 可能具有不同的疼痛过程，但需要进行随机试验才能得出明确结论。（临床试验注册号：NCT02249975.）。
