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Abstract：
BACKGROUND: The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear stapled anastomosis is a promising technique for MIE because it is quite feasible even without robotic assistance. The aim of the present study is to compare total MIE with linear stapled anastomosis to open esophagectomy (OE) with circular stapled anastomosis with special regard to postoperative morbidity in an expertise-based randomized controlled trial (RCT).
METHODS: This superiority RCT compares MIE with linear stapled anastomosis (intervention) to OE with circular stapled anastomosis (control) for Ivor-Lewis esophagectomy. It was initiated in February 2019, and recruitment is expected to last for 3 years. For inclusion, patients must be 18 years of age or more with a resectable primary malignancy in the distal esophagus. Participants with tumor localizations above the azygos vein, metastasis, or infiltration into adjacent tissue will be excluded. In an expertise-based approach, the allocated treatment will only be carried out by the single most experienced surgeon of the surgical center for each respective technique. The sample size was calculated with 20 participants per group for the primary endpoint postoperative morbidity according to comprehensive complication index (CCI) within 30 postoperative days. Secondary endpoints include anastomotic insufficiency, pulmonary complications, other intra- and postoperative outcome parameters such as estimated blood loss, operative time, length of stay, short-term oncologic endpoints, adherence to a standardized fast-track protocol, postoperative pain, and postoperative recovery (QoR-15). Quality of life (SF-36, CAT EORTC QLQ-C30, CAT EORTC QLQ-OES18) and oncological outcomes are evaluated with 60 months follow-up.
CONCLUSIONS: MIVATE is the first RCT to compare OE with circular stapled anastomosis to total MIE with linear stapled anastomosis exclusively for intrathoracic anastomosis. The expertise-based approach limits bias due to heterogeneity of surgical expertise. The use of a dedicated fast-track protocol in both OE and MIE will shed light on the role of the access strategy alone in this setting. The findings of this study will serve to define which approach has the best perioperative outcome for patients requiring esophagectomy.
BACKGROUND: German Clinical Trials Register DRKS00016773 . Registered on 18 February 2019.
METHODS: This superiority RCT compares MIE with linear stapled anastomosis (intervention) to OE with circular stapled anastomosis (control) for Ivor-Lewis esophagectomy. It was initiated in February 2019, and recruitment is expected to last for 3 years. For inclusion, patients must be 18 years of age or more with a resectable primary malignancy in the distal esophagus. Participants with tumor localizations above the azygos vein, metastasis, or infiltration into adjacent tissue will be excluded. In an expertise-based approach, the allocated treatment will only be carried out by the single most experienced surgeon of the surgical center for each respective technique. The sample size was calculated with 20 participants per group for the primary endpoint postoperative morbidity according to comprehensive complication index (CCI) within 30 postoperative days. Secondary endpoints include anastomotic insufficiency, pulmonary complications, other intra- and postoperative outcome parameters such as estimated blood loss, operative time, length of stay, short-term oncologic endpoints, adherence to a standardized fast-track protocol, postoperative pain, and postoperative recovery (QoR-15). Quality of life (SF-36, CAT EORTC QLQ-C30, CAT EORTC QLQ-OES18) and oncological outcomes are evaluated with 60 months follow-up.
CONCLUSIONS: MIVATE is the first RCT to compare OE with circular stapled anastomosis to total MIE with linear stapled anastomosis exclusively for intrathoracic anastomosis. The expertise-based approach limits bias due to heterogeneity of surgical expertise. The use of a dedicated fast-track protocol in both OE and MIE will shed light on the role of the access strategy alone in this setting. The findings of this study will serve to define which approach has the best perioperative outcome for patients requiring esophagectomy.
BACKGROUND: German Clinical Trials Register DRKS00016773 . Registered on 18 February 2019.
摘要：
背景：大多数食管癌的唯一治愈性治疗是根治性食管切除术。微创食管切除术（MIE）旨在降低术后发病率，但尚未广泛建立。线性吻合术是MIE的一种有前途的技术，因为即使没有机器人辅助，它也是非常可行的。本研究的目的是在一项基于专业知识的随机对照试验（RCT）中，比较总MIE与线性吻合术，开放食管切除术（OE）与圆形吻合术，并特别考虑术后发病率。
方法：这种优势RCT比较了Ivor-Lewis食管切除术中MIE和线性吻合术（介入）与OE和圆形吻合术（对照）。它于2019年2月启动，预计招聘将持续3年。为了纳入，患者必须年满18岁,在食管远端有可切除的原发性恶性肿瘤.肿瘤定位在奇静脉上方的参与者，转移,或浸润到邻近组织将被排除。在基于专业知识的方法中，所分配的治疗将仅由手术中心的最有经验的外科医生对每种技术进行。根据术后30天内的综合并发症指数（CCI），每组20名参与者计算主要终点术后发病率的样本量。次要终点包括吻合口功能不全，肺部并发症,其他术中和术后结果参数，如估计的失血量，手术时间,逗留时间,短期肿瘤终点，遵守标准化的快速通道协议，术后疼痛,和术后恢复（QoR-15）。生活质量（SF-36，CATEORTCQLQ-C30，CATEORTCQLQ-OES18）和肿瘤结局进行了60个月的随访。
结论：MIVATE是第一个将OE与圆形吻合术与完全MIE与线性吻合术进行比较的RCT，仅用于胸内吻合术。基于专业知识的方法限制了由于外科专业知识的异质性而产生的偏见。在OE和MIE中使用专用的快速通道协议将在此设置中单独阐明访问策略的作用。这项研究的结果将有助于确定哪种方法对需要食管切除术的患者具有最佳的围手术期结果。
背景：德国临床试验注册DRKS00016773。2019年2月18日注册。
方法：这种优势RCT比较了Ivor-Lewis食管切除术中MIE和线性吻合术（介入）与OE和圆形吻合术（对照）。它于2019年2月启动，预计招聘将持续3年。为了纳入，患者必须年满18岁,在食管远端有可切除的原发性恶性肿瘤.肿瘤定位在奇静脉上方的参与者，转移,或浸润到邻近组织将被排除。在基于专业知识的方法中，所分配的治疗将仅由手术中心的最有经验的外科医生对每种技术进行。根据术后30天内的综合并发症指数（CCI），每组20名参与者计算主要终点术后发病率的样本量。次要终点包括吻合口功能不全，肺部并发症,其他术中和术后结果参数，如估计的失血量，手术时间,逗留时间,短期肿瘤终点，遵守标准化的快速通道协议，术后疼痛,和术后恢复（QoR-15）。生活质量（SF-36，CATEORTCQLQ-C30，CATEORTCQLQ-OES18）和肿瘤结局进行了60个月的随访。
结论：MIVATE是第一个将OE与圆形吻合术与完全MIE与线性吻合术进行比较的RCT，仅用于胸内吻合术。基于专业知识的方法限制了由于外科专业知识的异质性而产生的偏见。在OE和MIE中使用专用的快速通道协议将在此设置中单独阐明访问策略的作用。这项研究的结果将有助于确定哪种方法对需要食管切除术的患者具有最佳的围手术期结果。
背景：德国临床试验注册DRKS00016773。2019年2月18日注册。
