Department of Digestive and Oncological Surgery, University Hospital, Place de Verdun, Lille, F-59037, France.
BMC Cancer. 2011 Jul 23;11:310. doi: 10.1186/1471-2407-11-310.
Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation) in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma.
METHODS/DESIGN: The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A.
Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery.
NCT00937456 (ClinicalTrials.gov).
开胸食管癌切除术是可切除的胸腔内食管癌的标准治疗方法，尽管它与高死亡率和高发病率相关，腹部和胸部入路的死亡率和发病率分别为 2%至 10%和 30%至 50%。腹腔镜技术在全球范围内的普及基于有前景的结果，包括较低的术后发病率，这与术后创伤的减少有关。我们假设在食管癌手术中使用腹腔镜腹部入路（腹腔镜胃动员）将降低主要术后并发症的发生率，这是由于手术创伤减少所致。
方法/设计：MIRO 试验是一项开放、对照、前瞻性、随机、多中心 III 期试验。研究组 A 的患者将接受腹腔镜辅助食管癌切除术，即经胸食管癌切除术和两野淋巴结清扫术联合腹腔镜胃动员。研究组 B 的患者将接受相同的手术，但采用传统的开腹腹部入路。该研究的主要目的是评估主要术后 30 天的发病率。次要目标是评估整体 30 天发病率、30 天死亡率、30 天肺部发病率、无病生存率、总生存率以及生活质量，并进行医疗经济学分析。将纳入 200 例患者，在研究组 A 中纳入 25 例和 50 例患者时将进行两次安全性分析。
食管癌手术后的术后发病率仍然很高，尤其是由于主要肺部并发症，这占术后死亡的 50%。这项研究代表了第一项评估微创方法在食管癌手术中对术后过程和肿瘤学结果的益处的随机对照 III 期试验。
NCT00937456（ClinicalTrials.gov）。
