Department of General-, Visceral- and Transplant Surgery, University Medical Center of the Johannes Gutenberg University, Langenbeckstrasse 1, D-55131, Mainz, Germany.
Institute for Medical Biometry, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
BMC Cancer. 2021 Sep 26;21(1):1060. doi: 10.1186/s12885-021-08780-x.
For patients with esophageal adenocarcinoma or cancer of the gastroesophageal junction, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison exists between MIE and RAMIE in the Western World for patients with esophageal adenocarcinoma.
This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group superiority trial. All adult patients (age ≥ 18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 218) with resectable esophageal adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction are randomized to either RAMIE (n = 109) or MIE (n = 109). The primary outcome of this study is the total number of resected abdominal and mediastinal lymph nodes specified per lymph node station.
This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction in the Western World. The hypothesis of the proposed study is that RAMIE will result in a higher abdominal and mediastinal lymph node yield specified per station compared to conventional MIE. Short-term results and the primary endpoint (total number of resected abdominal and mediastinal lymph nodes per lymph node station) will be analyzed and published after discharge of the last randomized patient within this trial.
ClinicalTrials.gov Identifier: NCT04306458 . Registered 13th March 2020, https://clinicaltrials.gov/ct2/show/NCT04306458; Date of first enrolment 18.01.2021; Target sample size 218; Recruitment status: Recruiting; Protocol version 2; Issue date 10.03.2020; Rev. 02.02.2021; Authors ET, PCvdS, PPG.
对于患有食管腺癌或胃食管交界处癌的患者，根治性食管切除术加 2 野淋巴结清扫术是具有治愈意图的多模式治疗的基石。与开胸食管切除术相比，传统的微创食管切除术（MIE）和机器人辅助微创食管切除术（RAMIE）在术后并发症方面均显示出优势。然而，在西方世界，对于患有食管腺癌的患者，尚未有 MIE 与 RAMIE 之间的随机对照比较。
这是一项由研究者发起并由研究者驱动的多中心随机对照平行组优效性试验。所有经组织学证实、可手术切除（cT1-4a、N0-3、M0）的胸内食管或胃食管交界处腺癌且欧洲临床肿瘤学会体力状况 0、1 或 2 级的成年患者（年龄≥18 岁且≤90 岁）将接受评估，以确定其是否符合纳入标准，并在获得知情同意后纳入研究。可切除的胸内食管腺癌或胃食管交界处腺癌患者（n=218）随机分为 RAMIE 组（n=109）或 MIE 组（n=109）。本研究的主要结局是指定的每个淋巴结站的腹部和纵隔淋巴结的总切除数。
这是第一项旨在比较 RAMIE 与 MIE 作为西方世界可切除食管腺癌或胃食管交界处腺癌的手术治疗方法的随机对照试验。该研究的假设是，与传统的 MIE 相比，RAMIE 会导致每个站指定的腹部和纵隔淋巴结的数量更高。短期结果和主要终点（指定的每个淋巴结站的腹部和纵隔淋巴结总切除数）将在该试验最后一名随机入组患者出院后进行分析和公布。
ClinicalTrials.gov 标识符：NCT04306458。注册于 2020 年 3 月 13 日，https://clinicaltrials.gov/ct2/show/NCT04306458；首次入组日期 2021 年 1 月 18 日；目标样本量 218；招募状态：招募；方案版本 2；发布日期 2020 年 3 月 10 日；修订 2021 年 2 月 2 日；作者 ET、PCvdS、PPG。
