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射频消融治疗 Barrett 食管低级别异型增生:一项随机试验的长期结果。

Radiofrequency ablation for low-grade dysplasia in Barrett's esophagus: long-term outcome of a randomized trial.

机构信息

Department of Gastroenterology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.

Department of Gastroenterology, St Antonius Hospital, Nieuwegein, the Netherlands.

出版信息

Gastrointest Endosc. 2020 Sep;92(3):569-574. doi: 10.1016/j.gie.2020.03.3756. Epub 2020 Mar 23.

Abstract

BACKGROUND AND AIMS

A prior randomized study (Surveillance versus Radiofrequency Ablation study [SURF study]) demonstrated that radiofrequency ablation (RFA) of Barrett's esophagus (BE) with confirmed low-grade dysplasia (LGD) significantly reduces the risk of esophageal adenocarcinoma. Our aim was to report the long-term outcomes of this study.

METHODS

The SURF study randomized BE patients with confirmed LGD to RFA or surveillance. For this retrospective cohort study, all endoscopic and histologic data acquired at the end of the SURF study in May 2013 until December 2017 were collected. The primary outcome was rate of progression to high-grade dysplasia (HGD)/cancer. All 136 patients randomized to RFA (n = 68) or surveillance (n = 68) in the SURF study were included. After closure of the SURF study, 15 surveillance patients underwent RFA based on patient preference and study outcomes.

RESULTS

With 40 additional months (interquartile range, 12-51), the total median follow-up from randomization to last endoscopy was 73 months (interquartile range, 46-85). HGD/cancer was diagnosed in 1 patient in the RFA group (1.5%) and in 23 in the surveillance group (33.8%) (P = .000), resulting in an absolute risk reduction of 32.4% (95% confidence interval [CI], 22.4%-44.2%) with a number needed to treat of 3.1 (95% CI, 2.3-4.5). Seventy-five of 83 patients (90%; 95% CI, 82.1%-95.0%) treated with RFA for BE reached complete clearance of BE and dysplasia. BE recurred in 7 of 75 patients (9%; 95% CI, 4.6%-18.0%), mostly minute islands or tongues, and LGD in 3 of 75 (4%; 95% CI, 1.4%-11.1%).

CONCLUSIONS

RFA of BE with confirmed LGD significantly reduces the risk of malignant progression, with sustained clearance of BE in 91% and LGD in 96% of patients, after a median follow-up of 73 months. (Clinical trial registration number: NTR1198.).

摘要

背景和目的

先前的一项随机研究(监测与射频消融研究[SURF 研究])表明,射频消融(RFA)治疗 Barrett 食管(BE)伴明确的低级别异型增生(LGD)可显著降低食管腺癌的风险。我们的目的是报告该研究的长期结果。

方法

SURF 研究将 BE 伴明确 LGD 的患者随机分为 RFA 或监测组。在这项回顾性队列研究中,我们收集了 2013 年 5 月 SURF 研究结束时直至 2017 年 12 月的所有内镜和组织学数据。主要结局是进展为高级别异型增生(HGD)/癌症的发生率。所有随机分配至 RFA(n=68)或监测(n=68)的 136 例 SURF 研究患者均纳入本研究。SURF 研究结束后,根据患者意愿和研究结果,有 15 例监测患者接受了 RFA。

结果

在增加了 40 个月(四分位间距,12-51)的随访后,从随机分组到最后一次内镜检查的中位总随访时间为 73 个月(四分位间距,46-85)。RFA 组有 1 例(1.5%)患者诊断为 HGD/癌症,而监测组有 23 例(33.8%)(P=0.000),绝对风险降低了 32.4%(95%置信区间[CI],22.4%-44.2%),需要治疗的人数为 3.1(95%CI,2.3-4.5)。83 例 RFA 治疗的 BE 患者中,75 例(90%;95%CI,82.1%-95.0%)达到了 BE 和异型增生完全清除。75 例 RFA 治疗的 BE 患者中,有 7 例(9%;95%CI,4.6%-18.0%)出现 BE 复发,大多为微小岛屿或舌状,3 例(4%;95%CI,1.4%-11.1%)出现 LGD。

结论

对于 BE 伴明确 LGD 的患者,RFA 可显著降低恶性进展风险,中位随访 73 个月后,91%的患者 BE 完全清除,96%的患者 LGD 完全清除。(临床试验注册号:NTR1198.)

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