Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial The MIRO Trial
Health-related Quality of Life Following Hybrid Minimally Invasive Versus Open Esophagectomy for Patients With Esophageal Cancer, Analysis of a Multicenter, Open-label, Randomized Phase III Controlled Trial The MIRO Trial
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DOI：
10.1097/sla.0000000000003559
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发表时间：
2020-06-01
影响因子：
9
通讯作者：
Piessen, Guillaume
中科院分区：
文献类型：
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作者：
Mariette, Christophe;Markar, Sheraz;Piessen, Guillaume
背景：与开放式食管切除术（OE）相比，混合微创食管切除术（HMIE）已被证明可以减少食管癌的主要术后并发症。目的：本研究的目的是在随机对照试验中比较 HMIE 和 OE 后的短期和长期健康相关生活质量 (HRQOL)。方法：我们于 2009 年至 2012 年间在 13 个研究中心进行了一项多中心、开放标签、随机对照试验。年龄为 18 至 75 岁、患有中段或下三分之一食管可切除癌症的患者被随机分配接受经胸 OE 或 HMIE。术后每 6 个月对患者进行一次随访，持续 3 年，并使用 EORTC-QLQC30 评估整体健康状况，并使用 EORTC-OES18 评估食管症状。结果：30 天时全球 HRQOL 的短期下降，特别是角色功能 [-33.33 (HMIE) 对比 -46.3 (OE)； P = 0.0407] 和社会功能 [-16.88 (HMIE) vs -35.74 (OE)； HMIE 组中 P = 0.0003] 的影响较小。 2 年时，HMIE 组的社会功能有所改善，超出基线 (+5.37)，但 OE 组的社会功能仍然下降 (-8.33) (P = 0.0303)。 2 年时，与 OE 组相比，HMIE 组的疼痛增加同样减少[+6.94 (HMIE) vs +14.05 (OE)； P = 0.018]。多变量分析显示术后并发症与角色功能、疼痛和吞咽困难相关。结论：食管切除术对短期 HRQOL 有显着影响。然而，使用 HMIE 可以减少对某些特定参数的这些影响，差异持续长达 2 年，并且可能是通过减少术后并发症来介导的。
Background: Hybrid minimally invasive esophagectomy (HMIE) has been shown to reduce major postoperative complications compared with open esophagectomy (OE) for esophageal cancer. Objectives: The aim of this study was to compare short- and long-term health-related quality of life (HRQOL) following HMIE and OE within a randomized controlled trial. Methods: We performed a multicenter, open-label, randomized controlled trial at 13 study centers between 2009 and 2012. Patients aged 18 to 75 years with resectable cancers of the middle or lower third of the esophagus were randomized to undergo either transthoracic OE or HMIE. Patients were followed-up every 6 months for 3 years postoperatively and global health assessed with EORTC-QLQC30 and esophageal symptoms assessed with EORTC-OES18. Results: The short-term reduction in global HRQOL at 30 days specifically role functioning [-33.33 (HMIE) vs -46.3 (OE); P = 0.0407] and social functioning [-16.88 (HMIE) vs -35.74 (OE); P = 0.0003] was less substantial in the HMIE group. At 2 years, social functioning had improved following HMIE to beyond baseline (+5.37) but remained reduced in the OE group (-8.33) (P = 0.0303). At 2 years, increases in pain were similarly reduced in the HMIE compared with the OE group [+6.94 (HMIE) vs +14.05 (OE); P = 0.018]. Postoperative complications in multivariate analysis were associated with role functioning, pain, and dysphagia. Conclusions: Esophagectomy has substantial effects upon short-term HRQOL. These effects for some specific parameters are, however, reduced with HMIE, with persistent differences up to 2 years, and maybe mediated by a reduction in postoperative complications.