Department of Surgery, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.
JAMA Surg. 2021 Jul 1;156(7):601-610. doi: 10.1001/jamasurg.2021.1555.
Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE.
To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial.
DESIGN, SETTING, AND PARTICIPANTS: This open, multicenter randomized clinical superiority trial was performed at 9 Dutch high-volume hospitals. Patients with midesophageal to distal esophageal or gastroesophageal junction cancer planned for curative resection were included. Data collection occurred from April 2016 through February 2020.
Patients were randomly assigned (1:1) to transthoracic MIE with intrathoracic or cervical anastomosis.
The primary end point was anastomotic leakage requiring endoscopic, radiologic, or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality, and quality of life.
Two hundred sixty-two patients were randomized, and 245 were eligible for analysis. Anastomotic leakage necessitating reintervention occurred in 15 of 122 patients with intrathoracic anastomosis (12.3%) and in 39 of 123 patients with cervical anastomosis (31.7%; risk difference, -19.4% [95% CI, -29.5% to -9.3%]). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference, -21.9% [95% CI, -32.1% to -11.6%]). Intensive care unit length of stay, mortality rates, and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with fewer severe complications (risk difference, -11.3% [-20.4% to -2.2%]), lower incidence of recurrent laryngeal nerve palsy (risk difference, -7.3% [95% CI, -12.1% to -2.5%]), and better quality of life in 3 subdomains (mean differences: dysphagia, -12.2 [95% CI, -19.6 to -4.7]; problems of choking when swallowing, -10.3 [95% CI, -16.4 to 4.2]; trouble with talking, -15.3 [95% CI, -22.9 to -7.7]).
In this randomized clinical trial, intrathoracic anastomosis resulted in better outcome for patients treated with transthoracic MIE for midesophageal to distal esophageal or gastroesophageal junction cancer.
Trialregister.nl Identifier: NL4183 (NTR4333).
经胸微创食管切除术（MIE）越来越多地作为根治性多模式治疗的一部分进行。关于经胸 MIE 后吻合口的最佳位置似乎没有强有力的证据。
在一项随机临床试验中比较经胸内与颈部吻合。
设计、地点和参与者：这是一项在荷兰 9 家高容量医院进行的开放、多中心随机临床优势试验。纳入计划进行根治性切除术的中食管至下段食管或胃食管交界处癌患者。数据收集于 2016 年 4 月至 2020 年 2 月进行。
患者被随机分配（1:1）接受经胸 MIE 治疗，采用经胸内或颈部吻合。
主要终点是需要内镜、放射或手术干预的吻合口漏。次要结局包括总体吻合口漏率、其他术后并发症、住院时间、死亡率和生活质量。
262 名患者被随机分组，245 名患者符合分析条件。在 122 例经胸内吻合的患者中，有 15 例（12.3%）和 123 例颈部吻合的患者中，有 39 例（31.7%）需要再次介入治疗的吻合口漏（风险差异，-19.4%[95%CI，-29.5%至-9.3%]）。在经胸内吻合组中，整体吻合口漏率为 12.3%，在颈部吻合组中为 34.1%（风险差异，-21.9%[95%CI，-32.1%至-11.6%]）。两组的重症监护病房住院时间、死亡率和总体生活质量相当，但经胸内吻合与较少的严重并发症相关（风险差异，-11.3%[-20.4%至-2.2%]），喉返神经麻痹发生率较低（风险差异，-7.3%[95%CI，-12.1%至-2.5%]），并且在 3 个亚领域的生活质量更好（平均差异：吞咽困难，-12.2[95%CI，-19.6 至-4.7]；吞咽时呛咳，-10.3[95%CI，-16.4 至 4.2]；说话困难，-15.3[95%CI，-22.9 至-7.7]）。
在这项随机临床试验中，对于接受经胸 MIE 治疗中食管至下段食管或胃食管交界处癌的患者，经胸内吻合可获得更好的结果。
Trialregister.nl 标识符：NL4183（NTR4333）。
