Departments of Internal Medicine II, Sana Hospital, Offenbach, Germany.
Department of Gastroenterology and Hepatology, University Hospital Frankfurt, Frankfurt am Main, Germany.
Am J Gastroenterol. 2022 Jan 1;117(1):110-119. doi: 10.14309/ajg.0000000000001539.
The current therapy of neoplastic Barrett's esophagus (BE) consists of endoscopic resection plus ablation, with radiofrequency ablation as the best studied technique. This prospective trial assesses a potential alternative, namely hybrid argon plasma ablation.
Consecutive patients with neoplastic BE undergoing ablation after curative endoscopic resection (89.6%) or primarily were included into this prospective trial in 9 European centers. Up to 5 ablation sessions were allowed for complete eradication of BE (initial complete eradication of intestinal metaplasia [CE-IM]), by definition including BE-associated neoplasia, documented by 1 negative endoscopy with biopsies. The main outcome was the rate of initial CE-IM in intention-to-treat (ITT) and per-protocol (PP) samples at 2 years. The secondary end points were the rate of recurrence-free cases (sustained CE-IM) documented by negative follow-up endoscopies with biopsies and immediate/delayed adverse events.
One hundred fifty-four patients (133 men and 21 women, mean age 64 years) received a mean of 1.2 resection and 2.7 ablation sessions (range 1-5). Initial CE-IM was achieved in 87.2% of 148 cases in the PP analysis (ITT 88.4%); initial BE-associated neoplasia was 98.0%. On 2-year follow-up of the 129 successfully treated cases, 70.8% (PP) or 65.9% (ITT) showed sustained CE-IM; recurrences were mostly endoscopy-negative biopsy-proven BE epithelium and neoplasia in 3 cases. Adverse events were seen in 6.1%.
Eradication and recurrence rates of Barrett's intestinal metaplasia and neoplasia by means of hybrid argon plasma coagulation at 2 years seem to be within expected ranges. Final evidence in comparison to radiofrequency ablation can only be provided by a randomized comparative trial.
目前,治疗肿瘤性 Barrett 食管(BE)的方法是内镜下切除加消融,射频消融是研究最多的技术。本前瞻性试验评估了一种潜在的替代方法,即混合氩等离子体消融。
本前瞻性试验纳入了 9 个欧洲中心的连续接受消融治疗的肿瘤性 BE 患者(89.6%为内镜下切除后)或初治患者。通过 1 次阴性内镜检查和活检来证明肠化生(CE-IM)完全消除,允许进行多达 5 次消融以完全消除 BE(定义包括 BE 相关肿瘤)。主要终点是意向治疗(ITT)和方案(PP)人群在 2 年时的初始 CE-IM 率。次要终点是通过阴性随访内镜检查和活检证明的无复发生存病例(持续 CE-IM)率,以及即时/延迟不良事件。
154 例患者(133 例男性,21 例女性,平均年龄 64 岁)平均接受 1.2 次切除术和 2.7 次消融术(范围 1-5 次)。PP 分析中 148 例患者中有 87.2%(ITT 为 88.4%)达到初始 CE-IM;初始 BE 相关肿瘤为 98.0%。在 129 例成功治疗病例的 2 年随访中,70.8%(PP)或 65.9%(ITT)显示持续的 CE-IM;3 例复发为内镜阴性活检证实的 BE 上皮和肿瘤。6.1%的患者出现不良事件。
混合氩等离子体凝固治疗 Barrett 肠化生和肿瘤在 2 年内的消除和复发率似乎在预期范围内。与射频消融相比,只有随机对照试验才能提供最终证据。