Luketich James D, Pennathur Arjun, Franchetti Yoko, Catalano Paul J, Swanson Scott, Sugarbaker David J, De Hoyos Alberto, Maddaus Michael A, Nguyen Ninh T, Benson Al B, Fernando Hiran C
*Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, PA †Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute, Harvard School of Public Health, Boston, MA ‡Department of Thoracic Surgery, Brigham and Women's Hospital, Boston, MA §Division of Hematology/Oncology, Department of Medicine, Northwestern University, Chicago, IL ¶Division of Thoracic and Foregut Surgery, Department of Surgery, University of Minnesota, Minneapolis ‖Division of Gastrointestinal Surgery, Department of Surgery, University of California Irvine Medical Center, Orange, CA **Department of Cardiothoracic Surgery, Boston Medical Center, Boston, MA.
Ann Surg. 2015 Apr;261(4):702-7. doi: 10.1097/SLA.0000000000000993.
The primary aim of this trial was to assess the feasibility of minimally invasive esophagectomy (MIE) in a multi-institutional setting.
Esophagectomy is an important, potentially curative treatment for localized esophageal cancer, but is a complex operation. MIE may decrease the morbidity and mortality of resection, and single-institution studies have demonstrated successful outcomes with MIE.
We conducted a multicenter, phase II, prospective, cooperative group study (coordinated by the Eastern Cooperative Oncology Group) 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 perioperative 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.
本试验的主要目的是评估在多机构环境下进行微创食管切除术（MIE）的可行性。
食管切除术是局部食管癌重要的、可能治愈的治疗方法，但手术复杂。MIE可能降低切除的发病率和死亡率，单机构研究已证明MIE有成功的结果。
我们开展了一项多中心、II期、前瞻性合作组研究（由东部肿瘤协作组协调）以评估MIE的可行性。经活检证实为高级别异型增生或食管癌的患者在17个符合资质的地点入组。方案手术包括三阶段MIE或艾弗·刘易斯MIE。主要终点是30天死亡率。次要终点包括不良事件、住院时间和3年结局。
104例符合初步分析条件的患者中有95例完成了方案手术（91.3%）。接受MIE的符合条件患者的30天死亡率为2.1%；所有符合初步分析条件的登记患者的围手术期死亡率为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级或更高等级的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%）和心房颤动（2.9%）。中位随访35.8个月时，估计3年总生存率为58.4%（95%置信区间：47.7%-67.6%）。仅7例患者（6.7%）发生局部区域复发。
这项前瞻性多中心研究表明，MIE是可行且安全的，围手术期发病率和死亡率低，肿瘤学结果良好。这种方法可被其他在开放食管切除术和微创手术方面有适当专业知识的中心采用。
