射频消融与混合氩离子凝固术治疗异型增生性巴雷特食管的比较：一项评估操作耐受性与安全性的随机对照试验（RATE研究）
Radiofrequency ablation versus hybrid argon plasma coagulation for dysplastic Barrett's esophagus: a randomized-controlled trial assessing procedural tolerability and safety (RATE study).
文献信息
| PMID | 42815697 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Robert Klimkowski |
| 作者单位 | Department of Oncological Gastroenterology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland. |
| 期刊 | Gastrointestinal endoscopy |
| SCI 分区 | Q1 |
| IF | 7.7 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景与目的： 射频消融（RFA）是异型增生性巴雷特食管（BE）的主要内镜治疗方法，但常与术后疼痛和吞咽困难相关。混合氩离子凝固术（h-APC）可能减少热损伤，同时保持疗效。我们旨在比较这两种方法的操作相关症状负担、安全性和有效性。
方法： 在这项单中心随机对照试验中，异型增生性BE患者按1:1随机分配接受RFA或h-APC。主要终点是每次消融后30天术后胸痛负担，定义为术后即刻、第7天和第30天获得的0-10视觉模拟评分（VAS）的曲线下面积（AUC）。次要终点包括吞咽困难负担、食管特异性生活质量（QoL）、不良事件、操作持续时间以及肠化生完全缓解（CR-IM）和异型增生完全缓解（CR-D）率。
结果： 共分析了62例患者的129次消融（67次RFA，62次h-APC）。每次治疗30天胸痛AUC平均值RFA高于h-APC（64.5±56.2 vs 40.5±47.3 VAS-天；P=0.010）。吞咽困难负担较低，但RFA后高于h-APC后（21.1±19.4 vs 14.4±17.5 Mellow-Pinkas评分（MPS）-天；P=0.043）。两组间QoL评分相似。RFA组6例（19.4%）和h-APC组1例（3.2%）发生食管狭窄。CR-IM率（67.7% vs 71.0%）和CR-D率（两组均为90.3%）相当。
结论： 与RFA相比，h-APC与较低的术后疼痛和吞咽困难负担以及数值上更少的消融后狭窄相关，同时实现相似的异型增生性巴雷特食管根除率。
英文摘要
BACKGROUND AND AIMS: Radiofrequency ablation (RFA) is the mainstay endoscopic therapy for dysplastic Barrett's esophagus (BE) but is frequently associated with postprocedural pain and dysphagia. Hybrid argon plasma coagulation (h-APC) may reduce thermal injury while maintaining efficacy. We aimed to compare procedure-related symptom burden, safety, and effectiveness of these two methods.
METHODS: In this single-center, randomized-controlled trial, patients with dysplastic BE were randomized 1:1 to receive RFA or h-APC. The primary endpoint was 30-day postprocedural chest-pain burden per ablation, defined as the area under the curve (AUC) of 0-10 visual analog scores (VAS) obtained immediately post-procedure, at day 7, and at day 30. Secondary endpoints included dysphagia burden, esophageal-specific quality of life (QoL), adverse events, procedure duration, and rates of complete remission of intestinal metaplasia (CR-IM) and dysplasia (CR-D).
RESULTS: In total, 129 ablation sessions (67 RFA, 62 h-APC) in 62 patients were analyzed. The mean 30-day chest pain AUC per session was higher with RFA than h-APC (64.5±56.2 vs 40.5±47.3 VAS-days; P=0.010). Dysphagia burden was low but greater after RFA than after h-APC (21.1±19.4 vs 14.4±17.5 Mellow-Pinkas score(MPS)-days; P=0.043). QoL scores were similar between groups. Esophageal strictures occurred in 6 patients (19.4%) in the RFA group and 1 (3.2%) in the h-APC group. Rates of CR-IM (67.7% vs 71.0%) and CR-D (90.3% in both groups) were comparable.
CONCLUSIONS: Compared with RFA, h-APC was associated with a lower postprocedural pain and dysphagia burden and numerically fewer post-ablation strictures, while achieving similar eradication rates of dysplastic Barrett's esophagus.