■SiewertII型食管胃交界处腺癌(SiewertIIAEG)可在微创条件下通过右胸腹手术入路(RTA)或经腹手术入路(TH)切除。虽然两种手术方法都能完全切除肿瘤,就手术安全性而言,前一种方法是否优于或至少不劣于后者存在争议。目前,少量的回顾性研究比较了两种手术方法,结果不确定。因此,需要一项前瞻性多中心随机对照试验来验证RTA(Ivor-Lewis)与TH相比的价值.
■计划的研究是一项前瞻性研究,多中心,随机临床试验。可以通过上述两种手术方法之一切除的SiewertIIAEG患者(n=212)将包括在该试验中,并随机分为RTA组(n=106)或TH组(n=106)。主要结果是3年无病生存期(DFS)。次要结果将包括5年总生存期(OS),术后并发症的发生率,术后死亡率,局部复发率,切除淋巴结的数量和位置,生活质量(QOL),手术Apgar评分,和操作的持续时间。手术后的前3年每3个月进行一次随访,后2年每6个月进行一次随访。
■在患有可切除肿瘤的SiewertIIAEG患者中,这是第一个前景,比较微创RTA和TH手术安全性的随机临床试验。假设RTA可以提供更好的消化道重建和纵隔淋巴结清扫,同时保持高质量的生活和良好的术后预后。此外,本试验将为SiewertIIAEG手术方式的选择提供高水平的证据.
■中国临床试验注册伦理委员会,标识符(ChiECRCT20210635);临床试验,标识符(NCT05356520)。
UNASSIGNED: Siewert type II adenocarcinoma of the esophagogastric junction (Siewert II AEG) can be resected by the right thoracoabdominal surgical approach (RTA) or abdominal-transhiatal surgical approach (TH) under minimally invasive conditions. Although both surgical methods achieve complete tumor resection, there is a debate as to whether the former method is superior to or at least noninferior to the latter in terms of surgical safety. Currently, a small number of retrospective studies have compared the two surgical approaches, with inconclusive results. As such, a prospective multicenter randomized controlled
trial is necessary to validate the value of RTA (Ivor-Lewis) compared to TH.
UNASSIGNED: The planned
study is a prospective, multicenter, randomized clinical
trial. Patients (n=212) with Siewert II AEG that could be resected by either of the above two surgical approaches will be included in this
trial and randomized to the RTA group (n=106) or the TH group (n=106). The primary outcome will be 3-year disease-free survival (DFS). The secondary outcomes will include 5-year overall survival (OS), incidence of postoperative complications, postoperative mortality, local recurrence rate, number and location of removed lymph nodes, quality of life (QOL), surgical Apgar score, and duration of the operation. Follow-ups are scheduled every three months for the first 3 years after the surgery and every six months for the next 2 years.
UNASSIGNED: Among Siewert II AEG patients with resectable tumors, this is the first prospective, randomized clinical
trial comparing the surgical safety of minimally invasive RTA and TH. RTA is hypothesized to provide better digestive tract reconstruction and dissection of mediastinal lymph nodes while maintaining a high quality of life and good postoperative outcome. Moreover, this
trial will provide a high level of evidence for the choice of surgical procedures for Siewert II AEG.
UNASSIGNED: Chinese Ethics Committee of Registering Clinical Trials, identifier (ChiECRCT20210635); Clinical Trial.gov, identifier (NCT05356520).