Minimally Invasive Versus Open Esophageal Resection Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial
Minimally Invasive Versus Open Esophageal Resection Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial
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DOI：
10.1097/sla.0000000000002171
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发表时间：
2017-08-01
影响因子：
9
通讯作者：
van der Peet, Donald L.
中科院分区：
文献类型：
--
作者：
Straatman, Jennifer;van der Wielen, Nicole;van der Peet, Donald L.
目的：本研究的目的是调查3年生存率以下的随机对照试验比较微创与开放式食管切除术在食管cancer.Background患者：微创食管切除术（MIE）的研究表明，更快的术后恢复和肺部并发症的显着减少。关于该手术在肿瘤学结局方面是否等同于开放切除术，争论仍在进行中。该研究是一项随访研究的时间-trial（传统的侵入性与微创食管切除术，多中心，随机试验）。方法：2009年6月至2011年3月，患者与可切除的胸内食管癌，包括胃食管连接部肿瘤（Siewert I），随机开放和MI食管切除术与治愈的意图。主要结局是3年无病生存率。次要结局包括总生存率、淋巴结转移率、短期发病率、死亡率、并发症、根治性、局部复发和转移。本试验在荷兰试验注册中心（NTR TC 2452）注册。两个试验方案和短期的结果已出版previous.Results：一百一十五例患者被纳入5个欧洲医院，并随机分配到开放（n = 56）或MI食管切除术（n = 59）。开放组的3年总生存率为40.4%（SD 7.7%），微创组为50.5%（SD 8%）（P = 0.207）。与开放手术相比，MIE的风险比（HR）为0.883（0.540 - 1.441）。开放手术组3年无病生存率为35.9%（SD 6.8%），MI组为40.2%（SD 6.9%）[HR 0.691（0.389 - 1.239）。结论：本研究显示开放手术和MI食管切除术的3年无病生存率和总生存率无差异。这些结果，连同短期结果，进一步支持使用微创手术技术治疗食管癌。
Objective: The aim of this study was to investigate 3-year survival following a randomized controlled trial comparing minimally invasive with open esophagectomy in patients with esophageal cancer.Background: Research on minimally invasive esophagectomy (MIE) has shown faster postoperative recovery and a marked decrease in pulmonary complications. Debate is ongoing as to whether the procedure is equivalent to open resection regarding oncologic outcomes. The study is a follow-up study of the TIME-trial (traditional invasive vs minimally invasive esophagectomy, a multicenter, randomized trial).Methods: Between June 2009 and March 2011, patients with a resectable intrathoracic esophageal carcinoma, including the gastroesophageal junction tumors (Siewert I), were randomized between open and MI esophagectomy with curative intent. Primary outcome was 3-year disease-free survival. Secondary outcomes include overall survival, lymph node yield, short-term morbidity, mortality, complications, radicality, local recurrence, and metastasis. Analysis was by intention-to-treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Both trial protocol and short-term results have been published previously.Results: One hundred fifteen patients were included from 5 European hospitals and randomly assigned to open (n = 56) or MI esophagectomy (n = 59). Combined overall 3-year survival was 40.4% (SD 7.7%) in the open group versus 50.5% (SD 8%) in the minimally invasive group (P = 0.207). The hazard ratio (HR) is 0.883 (0.540 to 1.441) for MIE compared with open surgery. Disease-free 3-year survival was 35.9% (SD 6.8%) in the open versus 40.2% (SD 6.9%) in the MI group [HR 0.691 (0.389 to 1.239).Conclusions: The study presented here depicted no differences in disease-free and overall 3-year survival for open and MI esophagectomy. These results, together with short-term results, further support the use of minimally invasive surgical techniques in the treatment of esophageal cancer.