Department of Surgery, Yokohama City University, Yokohama, Japan.
Jpn J Clin Oncol. 2013 Feb;43(2):214-6. doi: 10.1093/jjco/hys208. Epub 2012 Dec 12.
This randomized Phase II trial is being conducted to evaluate the impact of omentectomy for advanced gastric cancer on patient survival. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, intraoperative blood loss, length of the operation and postoperative morbidity (especially postoperative ileus). The planned sample size is 250 patients (125 for complete removal of the omentum and 125 for preservation of the omentum) to determine whether omentum-preserving gastrectomy may be a candidate procedure for a Phase III trial in a randomized Phase II setting.
这项随机的 II 期临床试验旨在评估网膜切除术对晚期胃癌患者生存的影响。主要终点是 3 年无复发生存率，次要终点是 5 年总生存率、术中出血量、手术时间和术后发病率（特别是术后肠梗阻）。计划的样本量为 250 例患者（125 例完全切除网膜，125 例保留网膜），以确定保留网膜的胃切除术是否可以作为随机 II 期设置下 III 期试验的候选方案。
