Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE),Gastrointestinal Endoscopy

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Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE)
Gastrointestinal Endoscopy ( IF 6.7 ) Pub Date : 2018-08-01 , DOI: 10.1016/j.gie.2018.07.031
Mohammad Farhad Peerally , Pradeep Bhandari , Krish Ragunath , Hugh Barr , Clive Stokes , Rehan Haidry , Laurence Lovat , Howard Smart , Rebecca Harrison , Karen Smith , Tom Morris , John S. de Caestecker

Background and Aims

Endoscopic resection (ER) is safe and effective for Barrett’s esophagus (BE) containing high-grade dysplasia (HGD) or mucosal adenocarcinoma (T1A). The risk of metachronous neoplasia is reduced by ablation of residual BE by using radiofrequency ablation (RFA) or argon plasma coagulation (APC). These have not been compared directly. We aimed to recruit up to 100 patients with BE and HGD or T1A confirmed by ER over 1 year in 6 centers in a randomized pilot study.

Methods

Randomization was 1:1 to RFA or APC (4 treatments allowed at 2-month intervals). Recruitment, retention, dysplasia clearance, clearance of benign BE, adverse events, healthcare costs, and quality of life by using EQ-5D, EORTC QLQ-C30, or OES18 were assessed up to the end of the trial at 12 months.

Results

Of 171 patients screened, 76 were randomized to RFA (n = 36) or APC (n = 40). The mean age was 69.7 years, and 82% were male. BE was <5 cm (n = 27), 5 to 10 cm (n = 45), and >10 cm (n = 4). Sixty-five patients completed the trial. At 12 months, dysplasia clearance was RFA 79.4% and APC 83.8% (odds ratio [OR] 0.7; 95% confidence interval [CI], 0.2-2.6); BE clearance was RFA 55.8%, and APC 48.3% (OR 1.4; 95% CI, 0.5-3.6). A total of 6.1% (RFA) and 13.3% (APC) had buried BE glands. Adverse events (including stricture rate after starting RFA 3/36 [8.3%] and APC 3/37 [8.1%]) and quality of life scores were similar, but RFA cost $27491 more per case than APC.

Conclusion

This pilot study suggests similar efficacy and safety but a cost difference favoring APC. A fully powered non-inferiority trial is appropriate to confirm these findings. (Clinical trial registration number: NCT01733719.)

中文翻译：

内镜切除Barrett食管中高度不典型增生或T1期腺癌后射频消融与氩气血浆凝结的比较：一项随机试验研究（BRIDE）

背景和目标

内镜切除术（ER）对于包含高度不典型增生（HGD）或粘膜腺癌（T1A）的Barrett食道（BE）是安全有效的。通过使用射频消融（RFA）或氩气血浆凝结（APC）消融残留的BE可以降低异时性瘤形成的风险。这些还没有直接比较。我们的目标是在随机先导研究中的6个中心招募多达100名经ER确认为1年以上的BE和HGD或T1A患者。

方法

RFA或APC的随机分配率为1：1（每2个月间隔进行4次治疗）。在试验结束前的12个月，评估了使用EQ-5D，EORTC QLQ-C30或OES18的招募，保留，异型清除率，良性BE清除率，不良事件，医疗保健费用和生活质量。

结果

在171名接受筛选的患者中，有76名被随机分配到RFA（n = 36）或APC（n = 40）。平均年龄为69.7岁，男性为82％。BE为<5 cm（n = 27），5至10 cm（n = 45）和> 10 cm（n = 4）。65名患者完成了试验。在12个月时，异型清除率分别为RFA 79.4％和APC 83.8％（赔率[OR] 0.7； 95％置信区间[CI]为0.2-2.6）；BE清除率是RFA 55.8％，APC 48.3％（OR 1.4； 95％CI，0.5-3.6）。共有6.1％（RFA）和13.3％（APC）掩埋了BE腺体。不良事件（包括开始RFA 3/36后的狭窄率[8.3％]和APC 3/37 [8.1％]）和生活质量得分相似，但RFA的费用比APC高27491美元。