Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study.
Minimally invasive esophagectomy: results of a prospective phase II multicenter trial-the eastern cooperative oncology group (E2202) study.
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DOI：
10.1097/sla.0000000000000993
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发表时间：
2015-04
影响因子：
9
通讯作者：
Fernando HC
中科院分区：
文献类型：
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作者：
Luketich JD;Pennathur A;Franchetti Y;Catalano PJ;Swanson S;Sugarbaker DJ;De Hoyos A;Maddaus MA;Nguyen NT;Benson AB;Fernando HC
该试验的主要目的是评估MIE在多机构环境中的可行性。食管癌切除术是治疗局限性食管癌的一种重要的、有潜在疗效的治疗方法，但它是一种复杂的手术。微创食管切除术（MIE）可以降低切除术的发病率和死亡率，单机构研究已经证明了MIE的成功结果。我们进行了一项多中心二期前瞻性合作小组研究（由ECOG协调），以评估MIE的可行性。活检证实的高级别不典型增生或食管癌患者在17个有资格的地点入选。方案手术包括三个阶段的MIE或Ivor Lewis MIE。主要终点为30天死亡率。次要终点包括不良事件、住院时间和3年结局。在符合初步分析条件的104例患者中，有95例（91.3%）完成了方案手术。接受MIE治疗的合格患者的30天死亡率为2.1%；所有符合初步分析条件的登记患者围手术期死亡率为2.9%。重症监护病房和住院时间的中位数分别为2天和9天。3级及以上不良事件包括吻合口漏（8.6%）、急性呼吸窘迫综合征（5.7%）、肺炎（3.8%）和房颤（2.9%）。在中位随访35.8个月时，估计3年总生存率为58.4%（95%可信区间：47.7%-67.6%）。局部复发仅7例（6.7%）。这项前瞻性多中心研究表明，MIE是可行和安全的，围手术期发病率和死亡率低，肿瘤预后良好。该方法可被其他具有开放性食管切除术和微创手术相关专业知识的中心采用。
The primary aim of this trial was to assess the feasibility of MIE in a multi-institutional setting. Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. Minimally invasive esophagectomy (MIE) may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE. We conducted a multi-center, phase II, prospective cooperative group study (coordinated by ECOG) to evaluate the feasibility of MIE. Patients with biopsy-proven high-grade-dysplasia or esophageal cancer were enrolled at 17 credentialed sites. Protocol surgery consisted of either 3-stage MIE or Ivor Lewis MIE. The primary end point was 30-day mortality. Secondary end points included adverse events, duration of hospital-stay, and 3-year outcomes. Protocol surgery was completed in 95 of the 104 patients eligible for the primary analysis (91.3%). The 30-day mortality in eligible patients who underwent MIE was 2.1%; perioperative mortality in all registered patients eligible for primary analysis was 2.9%. Median intensive care unit and hospital stay were 2 and 9 days, respectively. Grade 3 or higher adverse events included anastomotic leak (8.6%), acute respiratory distress syndrome (5.7%), pneumonitis (3.8%), and atrial fibrillation (2.9%). At a median follow-up of 35.8 months, the estimated 3-year overall survival was 58.4% (95% confidence interval: 47.7%–67.6%). Locoregional recurrence occurred in only 7 patients (6.7%). This prospective multicenter study demonstrated that MIE is feasible and safe with low peri-operative morbidity and mortality and good oncological results. This approach can be adopted by other centers with appropriate expertise in open esophagectomy and minimally invasive surgery.