Gastrointestinal Endoscopy ( IF 7.7 ) Pub Date : 2020-03-23 , DOI: 10.1016/j.gie.2020.03.3756 Roos E Pouw 1 , Esther Klaver 1 , K Nadine Phoa 1 , Frederike G van Vilsteren 1 , Bas L Weusten 2 , Raf Bisschops 3 , Erik J Schoon 4 , Oliver Pech 5 , Hendrik Manner 6 , Krish Ragunath 7 , Jacobo Ortiz Fernández-Sordo 7 , Grant Fullarton 8 , Massimiliano Di Pietro 9 , Wladyslaw Januszewicz 9 , Dermot O'Toole 10 , Jacques J Bergman 1
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.)
中文翻译:
射频消融治疗巴雷特食管低度不典型增生:一项随机试验的长期结果。
背景和目标
先前的一项随机研究(监测与射频消融研究[SURF研究])表明,巴雷特食管(BE)的射频消融(RFA)伴有低度发育不良(LGD)的确诊可显着降低食道腺癌的风险。我们的目的是报告这项研究的长期结果。
方法
SURF研究将确诊LGD的BE患者随机分配至RFA或监测。对于这项回顾性队列研究,收集了2013年5月至2017年12月SURF研究结束时获得的所有内镜和组织学数据。主要结局是进展为高度不典型增生(HGD)/癌症的速度。纳入SURF研究中随机分配至RFA(n = 68)或监测(n = 68)的所有136例患者。SURF研究结束后,根据患者的喜好和研究结果,对15名监测患者进行了RFA。
结果
再增加40个月(四分位间距为12-51),从随机分组到最后一次内镜检查的总中位随访时间为73个月(四分位间距为46-85)。在RFA组中有1名患者(1.5%)被诊断出HGD /癌症,在监测组中23名(33.8%)被诊断出HGD /癌症(P = .000),因此绝对风险降低了32.4%(95%置信区间[CI] ],22.4%-44.2%)和治疗3.1所需的数字(95%CI,2.3-4.5)。用RFA治疗BE的83例患者中有75例(90%; 95%CI,82.1%-95.0%)达到了BE的完全清除和不典型增生。75例患者中有7例(9%; 95%CI,4.6%-18.0%)复发,大部分为小岛或舌头复发,75例中3例(4%; 95%CI,1.4%-11.1%)复发。
结论
中位随访73个月后,经证实的LGD的BE的RFA显着降低了恶性进展的风险,BE的持续清除率为91%,LGD的持续清除率为96%。(临床试验注册号:NTR1198。)