Kim Guowei, Chen Elya, Tay Amy Yl, Lee Jin San, Phua Janelle Ns, Shabbir Asim, So Jimmy By, Tai Bee Choo
Department of Surgery, University Surgical Cluster, National University Health System, Singapore.
Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
Jpn J Clin Oncol. 2017 Feb 26;47(2):179-184. doi: 10.1093/jjco/hyw153.
Peritoneal recurrence after gastrectomy for gastric cancer is common and the prognosis is dismal. Recent evidence suggests that extensive peritoneal lavage with large volume of normal saline after surgery before abdominal closure can reduce the risk of peritoneal recurrence and improve overall survival. This study aims to evaluate the benefit of extensive intraoperative peritoneal lavage. This is a prospective, open-label, multicentre randomised controlled trial involving 15 international centres in China, Korea, Japan, Malaysia and Singapore. Patients with cT3/4 stomach cancer undergoing curative resection are randomised to either extensive peritoneal lavage (10 l of saline) or standard lavage (≤2 l of saline). The primary outcome is overall survival and secondary outcomes include disease-free survival and peritoneal recurrence. The minimum sample size is 600 subjects with 300 per arm completing 3 years follow-up. The data will be analysed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance.
胃癌胃切除术后腹膜复发很常见，预后很差。最近的证据表明，在手术结束前腹腔关闭前用大量生理盐水进行广泛的腹腔灌洗可降低腹膜复发风险并提高总生存率。本研究旨在评估广泛术中腹腔灌洗的益处。这是一项前瞻性、开放标签、多中心随机对照试验，涉及中国、韩国、日本、马来西亚和新加坡的15个国际中心。接受根治性切除的cT3/4期胃癌患者被随机分为广泛腹腔灌洗组（10升生理盐水）或标准灌洗组（≤2升生理盐水）。主要结局是总生存率，次要结局包括无病生存率和腹膜复发。最小样本量为600名受试者，每组300名，完成3年随访。数据将按意向性分析，假设双侧检验，显著性水平为5%。
