Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France
Gastroenterology and Endoscopy, Groupement Hospitalier Edouard Herriot, Lyon, Rhône-Alpes, France.
Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.
OBJECTIVE: Due to an annual progression rate of Barrett's oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design. DESIGN: A prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity. RESULTS: 125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%). CONCLUSION: RFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD. TRIAL REGISTRATION NUMBER: NCT01360541.
目的:由于每年 Barrett 食管(BO)伴低级别上皮内瘤变(LGD)的进展率为 9%至 13%,因此内镜消融治疗优于监测。由于这一建议仅基于一项随机试验,我们旨在通过另一项设计相似的多中心随机试验来验证这些结果。
设计:在 14 个中心进行了一项前瞻性随机研究,比较了射频消融(RFA)(最多 4 次)与每年的内镜监测,包括确诊为 BO 伴 LGD 的患者。主要结局是 3 年时 LGD 的患病率。次要结局是 1 年时 LGD 的患病率、3 年时肠化生完全消除(CE-IM)的比例、3 年时肿瘤进展的发生率和与治疗相关的发病率。
结果:最初纳入了 125 例患者,其中 82 例经证实有 LGD(76 例男性,平均年龄 62.3 岁)最终被随机分组,40 例患者接受 RFA,42 例患者接受监测。3 年时,RFA 组和监测组的 CE-IM 率分别为 35%和 0%(p<0.001)。同时,RFA 组 LGD 的患病率为 34.3%(95%CI 18.6%至 50.0%),监测组为 58.1%(95%CI 40.7%至 75.4%)(OR=0.38(95%CI 0.14 至 1.02),p=0.05)。肿瘤进展发生率分别为 12.5%(RFA)和 26.2%(监测;p=0.15)。RFA 治疗后首次出现的并发症发生率最高(16.9%)。
结论:RFA 适度降低了 3 年时 LGD 的患病率和进展风险。因此,对于确诊为 BO 伴 LGD 的患者,内镜消融治疗的风险效益平衡应仔细权衡与监测。
试验注册:NCT01360541。
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